Genito-Urinary Disease Site

Genito-Urinary

ID Sort	Study Title	Status Sort
PR25	A Phase III Trial Investigating Platinum and Taxane Chemotherapy in Metastatic Castration Resistant Prostate Cancer Patients with Alterations in DNA Damage Response Genes Read More Complexity Level: 2 NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Planned Chair: (Canada) Dr. Michael Kolinsky, Cross Cancer Institute, (780) 432-8762	Planned
BLC5 (ALLIANCE A032001)	MAIN-CAV: Phase III Randomized Trials of Maintenance Cabozantinib and Avelumab vs Maintenance Avelumab After First-Line Platinum Based Chemotherapy in Patients with Metastatic Urothelial Cancer Testing the addition of the anti-cancer drug, cabozantinib, to the usual immunotherapy treatment, avelumab, in patients with metastatic urothelial cancer Read More Complexity Level: 2 Eligibility: - Histologically or cytologically-confirmed diagnosis of advanced or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra, including N3 only disease prior to start of first-line platinum-based chemotherapy. -Prior first-line treatment must have consisted of 4-6 cycles of 1st-line therapy. -No more than 1 line of prior chemotherapy for metastatic or locally advanced disease. -Tumor objective response of CR, PR, or SD upon completion of first line platinum-based chemotherapy. - The last dose of first-line chemotherapy must have been received no less than 3 weeks, and no more than 10 weeks, prior to randomization in the present study. -No prior immunotherapy with IL-2, IFN-?, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. - 18 years or older. - ECOG Performance Status of 0 or 1. Objectives: Primary objective: To evaluate the effect of cabozantinib in combination with avelumab on OS compared to avelumab alone in patients with mUC who did not progress during first-line platinum-based chemotherapy therapy. Secondary Objectives: To evaluate progression-free survival (PFS), safety and tolerability and, activity of cabozantinib in combination with avelumab compared to avelumab alone. Quality of Life (QOL) Objectives: to compare quality of life measures using EQ-5D-5L, PROMIS-Figure4a, EORTC QLQ-C30, and EORTC-BLM30. NCT Registration ID (from clinicaltrials.gov): NCT05092958 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Open to Accrual Activation Date: October 04, 2022 Chair: (Canada) Dr. Srikala Sridhar, University Health Network, (416) 946-4501 Ext. 2520	Open to Accrual
GCC1 (SWOG S1823)	A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell Tumours Read More Complexity Level: 3 Eligibility: Male or female patients must have a new diagnosis of a germ cell tumor. If surgery is planned, male patients with CSI Clinical Stage I testicular cancer must have orchiectomy completed within 42 days prior to registration. All primary sites, stages, histological subtypes of germ cell tumor and metachronous secondary germ cell tumors are eligible. Patients must be registered within 42 days after diagnosis and prior to initiation of a management plan or treatment for the disease. Additionally, within 42 days prior to registration, patients must: have initial imaging, laboratory and other clinical evaluations performed as defined in the protocol and have beta-human chorionic gonadotropin (beta- HCG), alpha-fetoprotein (AFP), and lactate dehydrogenase (LDH) assessments. Finally patients must: be >/= 18 years of age, have risk of relapse assessment determined by the local investigator prior to registration and agree to submit required specimens for defined translational medicine studies. Objectives: Primary Objective To estimate the positive predictive value within each of the early stage seminoma and non-seminoma groups using plasma miRNA 371 expression at relapse to detect germ cell malignancy. Secondary Objectives a. To bank prospectively obtained serial liquid biospecimens for low and moderate risk of relapse patients annotated by patient level clinical data. b. To bank prospectively collected, clinically annotated specimens for high risk patients and non-testicular primary patients in collaboration with Children's Oncology Group study AGCT 1531. NCT Registration ID (from clinicaltrials.gov): NCT04435756 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Open to Accrual Activation Date: August 27, 2020 Chair: (Canada) Dr. Lucia Nappi, BCCA - Vancouver Cancer Centre, (604) 877-6000	Open to Accrual
I234	Prostate Cancer Biomarker Enrichment and Treatment Selection (PC_BETS) Study - Master Screening Protocol The purpose of the pre-study screening is to test for DNA abnormalities or "markers". This testing will be done on a sample of your blood to see whether or not you are eligible to take part in one of the main studies. Each study will be looking at what effects a new drug or drugs has on you and your prostate cancer and will also be looking at the side effects of treatment. The researchers doing the main studies will be looking to see if the "markers" that were identified in your screening sample can help predict which patients are most likely to be helped by that drug or drugs and to see how the cancer cells respond to it/them. Read More Complexity Level: 1 Eligibility: Patients (>=18 years old, ECOG PS 0-1) must have histologically confirmed mCRPC with no evidence of small cell/neuroendocrine differentiation. Patients must consent to undergo genomic screening. Clinically/radiologically documented disease (measurable or non-measurable). Evidence of biochemical and/or radiological disease progression in the setting of surgical or medical castration. Patients must have received prior hormonal treatment with at least one of abiraterone acetate, enzalutamide, ARN-509 TAK-700 and TOK-001. Prior anti-androgen therapy must have been discontinued >=28 days (>=42 days for bicalutamide) prior to registration. Maximum of one prior regimen of cytotoxic chemotherapy permitted. Prior immunotherapy, vaccines and oncolytic viruses permitted. Prior/concurrent CDK or mTOR inhibitors, strontium-89, systemic corticosteriods equivalent to prednisone >10 mg daily not allowed. Objectives: Primary Objective - To centrally genotype cfDNA from patients with mCRPC progressing after a "next-generation" AR-pathway inhibitor in order to facilitate accrual to targeted therapy trials and then to assess the clinical benefit rate (CBR), of each Study Drug. Secondary Objectives - To determine the effect of each Study Drug on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of each Study Drug in mCRPC patients. Tertiary Objectives - To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation. NCT Registration ID (from clinicaltrials.gov): NCT03385655 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: December 12, 2017 Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746	Open to Accrual
I234B	A Phase II Study of Savolitinib, A CMET Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234 The purpose of this study is to find out what effects a new drug, savolitinib, has on prostate cancer and will look at the side effects of treatment with savolitinib. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by savolitinib and to see how the cancer cells respond to savolitinib. Read More Complexity Level: 1 Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234.Men of childbearing potential must have agreed to use a highly effective contraceptive method during Study Drug treatment and for 6 months after stopping treatment and should not father a child or donate sperm during this period. Patients with significantly abnormal liver diseases including viral/other hepatitis, current alcohol abuse or cirrhosis are not eligible. Patients in whom strong inducers or inhibitors of CYP3A4 and strong inhibitors of CYP1A2 cannot be discontinued within 2 weeks before the first dose of savolitinib (3 weeks for St John's Wort) are not eligible.. Objectives: To determine the effect of savolitinib on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of savolitinib in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation. NCT Registration ID (from clinicaltrials.gov): NCT03385655 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: December 12, 2017 Chair: (Canada) Dr. Som Mukherjee, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64605	Open to Accrual
I234C	A Phase II Study of Darolutamide (ODM-201) in Patients with Metastatic Castration-Resistant Prostate Cancer Previously Treated with Abiraterone Acetate or Enzalutamide - A Sub-Study of IND.234 The purpose of this study is to find out what effects a new drug, darolutamide, has on prostate cancer and will look at the side effects of treatment with darolutamide. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by darolutamide and to see how the cancer cells respond to darolutamide. Read More Complexity Level: 1 Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234. Serum potassium within normal limits. Prior abiraterone acetate or enzalutamide but not both. No prior cytotoxic systemic chemotherapy in the CRPC setting. Objectives: To determine the effect of darolutamide on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of darolutamide in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation. NCT Registration ID (from clinicaltrials.gov): NCT03385655 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: December 12, 2017 Chair: (Canada) Dr. Michael Ong, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 75051	Open to Accrual
I234E	A Phase II Study of Ipatasertib in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients with PI3K Pathway Alterations in Circulating Tumour DNA (ctDNA) The purpose of this study is to find out what effects a new drug, ipatasertib, has on prostate cancer and will look at the side effects of treatment with ipatasertib. The researchers doing this study are also interested in looking at how the cancer cells respond to ipatasertib. Read More Complexity Level: 1 Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234. Patients must have adequate hematologic and organ function (AST <= 1.5 x ULN, fasting glucose <= 8.3 mmol/L, glycated hemoglobin <= 7.5%, serum albumin >= 3.0 g/L). Patients with Type 1 or Type 2 diabetes mellitus requiring insulin at study entry must be on a stable dose of diabetes medication for >=4 weeks. Patients must not have uncontrolled/untreated hypercholesterolemia or hypertriglyceridemia, require chronic therapy or use of food supplements that are strong CYP3A4/5 inducers or inhibitors or sensitive substrates of CYL3A or CYP2D6 with a narrow therapeutic window, or prior treatment with therapeutics with known inhibition of the PI3K pathway (including PI3K inhibitors, AKT inhibitors, and mTOR inhibitors). Objectives: To determine the effect of ipatasertib on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of ipatasertib in mCRPC patients. Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: December 27, 2019 Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746	Open to Accrual
I234F	A Phase II Study of Durvalumab and Tremelimumab in Metastatic Castration-Resistant Prostate Cancer The purpose of this study is to find out what effects a combination of two drugs, durvalumab and tremelimumab, has on prostate cancer and will look at the side effects of treatment with the combination. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by this combination of drugs and to see how the cancer cells respond to durvalumab and tremelimumab. Read More Complexity Level: 1 Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234. Patients must not have received prior immune checkpoint inhibitors (anti-PD-(L)1 and/or anti CTLA-4). Patients may not have active or prior documented autoimmune or inflammatory disorders, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome, rheumatoid arthritis, hypophysitis, uveitis, etc. within the past 3 years except alopecia, Grave's disease vitiligo or psoriasis not requiring systemic treatment within the last 2 years, or hypothyroidism stable on hormone replacement. Patients must not have live attenuated vaccination administered within 30 days prior to enrollment or within 30 days of receiving durvalumab. Objectives: To determine the effect of durvalumab and tremelimumab on PSA decline and time to PSA progression. To determine objective response as determined by iRECIST criteria. To evaluate the safety and toxicity profile of durvalumab and tremelimumab in mCRPC patients. To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation. Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Open to Accrual Activation Date: December 27, 2019 Chair: (Canada) Dr. Sebastien Hotte, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64605	Open to Accrual
I234G	A Phase II Study of Carboplatin in Patients with Metastatic Castration-Resistant Prostate Cancer The purpose of this study is to find out what effects carboplatin has on prostate cancer and will look at the side effects of treatment The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by carboplatin and to see how the cancer cells respond this treatment. Read More Complexity Level: 1 Eligibility: Patients must fulfill all of the criteria set out in Section 4.0 of the main protocol AND the following eligibility/ineligibility criteria and timings specific to carboplatin to be eligible for enrollment to the substudy. Renal function defined by serum creatinine < 1.25 x ULN and creatinine clearance >/= 50 mL/min. Patients who have a severe allergic reaction to platinum-containing compounds, who had live attenuated vaccination administered within 30 days prior to enrollment or within 30 days of receiving carboplatin, or need for concomitant treatment with nephrotoxic drugs are not eligible. Objectives: To determine the effect of carboplatin on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To summarize progression free and overall survival. To evaluate the safety and toxicity profile of carboplatin in mCRPC patients. To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation. NCT Registration ID (from clinicaltrials.gov): NCT03385655 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: June 10, 2020 Chair: (Canada) Dr. Zineb Hamilou, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8000 Ext. 20688	Open to Accrual
PR19	A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer The purpose of this study is to evaluate the dose of High Dose Rate (HDR) brachytherapy chosen for this study as well as a commonly used alternate form of brachytherapy called low dose rate (or seed) brachytherapy. Investigators would like to understand how these treatments control prostate cancer and look at their short and long term treatment related side effects. Read More Complexity Level: 1 Eligibility: Patients enrolled in this study must have histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months and have low- (clinical stage T1-T2 and Gleason 6 and PSA <20 ng/mL) or intermediate-risk (clinical stage T1-T2 and Gleason 7 (3+4) and PSA < 15 ng/mL and < 50% of positive cores) prostate cancer. Objectives: Primary objective: prostate cancer control as defined by 48 month PSA values Secondary objectives: Disease-free survival, PSA progression, PSA nadir, local disease progression, regional disease progression, regional disease progression, distant disease progression, acute and long term toxicity and safety, Quality of Life (QOL) of the patient and their spouse/partner, resource utilization and economic indices of treatment administration. Tertiary objective: To establish a comprehensive tumour bank linked to a clinical database for the further study of predictive and prognostic biomarkers in prostate cancer. NCT Registration ID (from clinicaltrials.gov): NCT02960087 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: November 04, 2016 Chair: (Canada) Dr. Eric Vigneault, CHUQ - Hotel Dieu de Quebec, (418) 691-5264, (Canada) Dr. Gerard Morton, Odette Cancer Centre, (416) 480-6165	Open to Accrual
PR20	A Randomized Phase III Trial of Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer [PLATON] The purpose of this study is to compare the effects of standard treatment to standard treatment plus ablative therapy (Radiotherapy or surgery) to all sites of disease in patients with oligometastatic hormone sensitive prostate cancer. It is not clear if ablative therapy (SBRT for example) to all sites of disease used in combination with standard treatments such as hormone therapy and/or chemotherapy can offer better results than standard treatment alone. This study will also obtain important information about the effects of treatment on qualtiy of life, cost effectiveness, as well as predictive and prognostic correlative markers. Read More Complexity Level: 2 Eligibility: (1) Male, aged 18 years or older, (2) Histologically-proven oligometstatic adenocarcinoma of the prostate and no evidence of small cell cancer,(3) Stage: IV (newly diagnosed at presentation or relapse after curative intent therapy); M1 dx less than/= to 5 mets; N1 disease can be included as site of metastases only in patients in relapse after curative intent prostate surgery or radiotherapy (4) Less than/= 3 mets in any non-bone organ system (5) All patients must receive Zoladex (LHRHa),(6)all tumours must be amenable to local ablative therapy (Radiation or surgery),(7) ECOG PS 0-1, (8)patient is medically suitable for all treatment options. EXCLUSION: prior adj/neoadj ADT, unless stopped >12 months & 36 mo. max duration; recurrent/metstatic disease previously treated with systemic or radiation therapy; Castration resistant prostate cancer (per PCWG3); Untreated pelvic lymph nodes as only site of disease; inability to treat all sites of disease with LAT; parenchymal brain mets. Objectives: Primary objective: To compare failure free survival between patients with oligometastatic HSPC treated with standard systemic therapy plus ablative therapy to untreated prostate primary in patients with low volume metastatic disease burden versus standard systemic therapy plus local ablative therapy to all sites of disease. Secondary objectives: Radiographic Progression Free Survival; Incidence of new metastases as first event; Overall survival; Ablative treatment related adverse events (grade 3 or greater); Quality of Life (QOL); Economic analysis. Tertiary objectives: Correlative exploratory studies such as immunophenotyping to understand mechanisms of resistance to SBRT when added to standard systemic therapy and identify predictive/prognostic markers in the trial population, and to create a biorepository of tissue and blood for future correlative studies. NCT Registration ID (from clinicaltrials.gov): NCT03784755 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: April 18, 2019 Chair: (Canada) Dr. Patrick C.F. Cheung, Odette Cancer Centre, (416) 480-6165, (Canada) Dr. M. Tamim Niazi, The Jewish General Hospital, (514) 340-8288	Open to Accrual
PR21	A Randomized Phase II Study of 177Lu-PSMA-617 vs Docetaxel in Patients with Metastatic Castration-Resistant Prostate Cancer and PSMA-Positive Disease Metastatic castration-resistant prostate cancer (mCRPC) leads to the death of over 30,000 North American men and over 4,000 Canadian men each year. More potent agents that inhibit the main driver of mCRPC - the reactivated androgen receptor (AR) - have now entered our standard therapy armamentarium and have substantially improved clinical outcomes for patients with mCRPC (i.e. abiraterone, enzalutamide). However, primary resistance or early disease progression occurs in 10-20% of patients, and secondary resistance will eventually occur in all patients. 177Lu-PSMA appears to have activity in patients with heavily pre-treated mCRPC that have received several lines of therapy. This novel 177Lu-PSMA therapy and its promising early data supports the need to further prospectively investigate the safety, tolerability, and anti-tumor activity of 177Lu-PSMA in mCRPC patients. 177Lu-PSMA is a potentially less toxic therapeutic option. Hence, we aim to examine the clinical efficacy of this therapy in an mCRPC patient population with less advanced disease, following progression on AR-targeted therapy, compared to standard docetaxel chemotherapy. Thus, we propose a Phase II Study of 177Lu-PSMA-617 in mCRPC Patients with PSMA-Positive Disease, who have previously received treatment with AR-targeted therapy, compared to docetaxel. Read More Complexity Level: 2 Eligibility: Inclusion: 1. Progression on treatment with abiraterone and/or enzalutamide, or similar next generation androgen receptor (AR) targeted therapy 2.Evidence of PSMA positive metastatic disease, as assessed on PSMA-ligand PET/CT or PSMA-ligand PET/MR 3. Biopsy-proven prostate cancer with no evidence of small cell component 4. Prior orchiectomy, or if on LHRH agonist/antagonist then testosterone 5. Patients must have castration resistance with prior evidence of biochemical or imaging progression in the setting of surgical/medical castration Objectives: (Primary): To compare radiographic progression-free survival (rPFS) of patients with metastatic castration-resistant prostate cancer (mCRPC) treated with 177Lu-PSMA radioligand therapy vs. docetaxel in the post androgen receptor (AR)-targeted therapy setting. (Secondary): Second rPFS in patients who meet criteria for rPFS and crossover to the alternate therapy (Secondary):Time to commencement of third line therapy (Secondary): Overall survival (Secondary):proportion of patients with decreased PSA from baseline and the magnitude of change (Secondary):Clinical benefit rate (CBR) and response duration including partial response (PR), complete response (CR) or stable disease > 24 weeks (Secondary): Determine adverse event (AE) profile (Secondary): Patient reported QOL (Secondary): Cost-effectiveness (Tertiary): explore biomarkers of response and resistance using cell free DNA (Tertiary): retrospectively explore a dosimetry-based approach to determine administered activity. NCT Registration ID (from clinicaltrials.gov): NCT04663997 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Open to Accrual Activation Date: December 17, 2020 Chair: (Canada) Dr. Francois Benard, BCCA - Vancouver Cancer Centre, (604) 675-8206, (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746, (Canada) Dr. Fred Saad, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8000 Ext. 27466	Open to Accrual
PR22 (ANZUP 1801)	DASL-HiCaP: Darolutamide Augments Standard Therapy for Localized Very High-Risk Cancer of the Prostate. A Randomized Phase III Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localized Prostate Cancer The purpose of this study is to determine the effectiveness of darolutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at very high risk of recurrence. Read More Complexity Level: 2 Eligibility: Men with either very high risk localised prostate cancer or very high risk features with PSA persistence/rise within 12 months following radical prostatectomy, suitable for EBRT with or without brachytherapy. CT/MRI and bone scan negative for distant metastases (allow pelvic LN). Objectives: Primary: Metastasis-free survival Secondary: Overall survival; prostate cancer-specific survival; PSA-progression free surival; time to subsequent hormonal therapy; time to castration-resistance; frequency and esverity of adverse events; health-related QoL; fear of cancder recurrence Tertiary: Incremental cost-effectiveness; prognostic/predictive biomarkers NCT Registration ID (from clinicaltrials.gov): NCT04136353 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Open to Accrual Activation Date: November 27, 2020 Chair: (Canada) Dr. M. Tamim Niazi, The Jewish General Hospital, (514) 340-8288	Open to Accrual
BL13	A Randomized Phase II Trial Assessing Trimodality Therapy With or Without Adjuvant Durvalumab (MEDI4736) to Treat Patients with Muscle-Invasive Bladder Cancer Read More Complexity Level: 2 Eligibility: Histologic diagnosis of transitional cell carcinoma of the bladder with completion of prior trimodality therapy (surgery, chemotherapy and radiation) at least 42 days prior to study enrollment. Stage T2-T4a N0M0. Objectives: The overall objective of this phase II randomized trial is to determine if Durvalumab when used in combination following standard trimodality therapy improves disease-free-survival when compared to surveillance alone in patients with T2 or more muscle-invasive bladder cancer. NCT Registration ID (from clinicaltrials.gov): NCT03768570 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: December 21, 2018 Closing Date: January 31, 2023 Chair: (Canada) Dr. Wassim Kassouf, The Research Institute of the McGill University, (514) 934-8246	Closed to Accrual
BL13F	Electronic 'Real-Time' Patient Self-Reporting of Immunotherapy Symptomatic Adverse Events using the SYMPTOM-IQ Tool on the uMotif Mobile Health Application (APP): A Prospective Feasibility Sub-Study of BL13 [e-PRISM] Read More Complexity Level: 2 Eligibility: Participants on both arms of the main BL.13 study are eligible for the BL.13F sub-study. Participants must be willing to complete symptom reports on a mobile phone application in English or French. Objectives: To assess feasibility (recruitment, retention, adherance) and acceptability of remote patient self-reporting of ten common symptomatic immune-related adverse events, using the uMotif mobile phone application. NCT Registration ID (from clinicaltrials.gov): no NCT Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: July 15, 2020 Closing Date: January 31, 2023 Chair: (Canada) Dr. Doris Howell, University Health Network, (416) 946-4501 Ext. 3419	Closed to Accrual
BLC1 (SWOG S1011)	A Phase III Surgical Trial to Evaluate the Benefit of a Standard versus an Extended Pelvic Lymphadenectomy Performed at the Time Of Radical Cystectomy For Muscle Invasive Urothelial Cancer Read More Complexity Level: 2 Eligibility: Patients must have histologically-proven (T2, T3, or T4a) urothelial carcinoma of the bladder (UCB) that requires primary radical cystectomy for definitive treatment. Objectives: Primary: To compare disease-free survival (DFS) in eligible patients treated with radical cystectomy and extended pelvic lymph node dissection (PLND) compared to radical cystectomy and standard pelvic lymphadenectomy. Secondary: To compare overall survival (OS) between extended PLND versus standard pelvic lymphadenectomy. To evaluate operative time, whether nerve sparing was performed, morbidity and mortality, length of hospital stay, histology, lymph node counts density, adjuvant chemotherapy, and local and retroperitoneal soft tissue recurrence. Proximal extent of node dissection in those patients randomized to extended PLND will be evaluated as well. Translational Medicine Objectives: a. To bank paraffin embedded blocks or slides of the primary tumor, b. To determine the prognostic value of putative markers of the premetastatic niche, c. To evaluate if the prevalence of pre-metastatic niche is different between patients that received neoadjuvant chemotherapy and those who did not. NCT Registration ID (from clinicaltrials.gov): NCT01224665 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: January 15, 2014 Closing Date: February 15, 2017 Chair: (Canada) Dr. Wassim Kassouf, The Research Institute of the McGill University, (514) 934-8246	Closed to Accrual
BLC4 (SWOG S1605)	Phase II Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder Cancer Read More Complexity Level: 2 Eligibility: Patients with histologically proven, recurrent, non-muscle invasive urothelial carcinoma of the bladder within 60 days prior to registration. The carcinoma must be Stage T1 High-Grade, Stage CIS, or Stage Ta High-Grade. Patients with mixed urothelial carcinoma and a glandular and/or squamous component will be eligible for the trial, but the presence of other histologic variants, pure adenocarcinoma, or pure squamous cell carcinoma, will make a patient ineligible. Patients must be deemed unfit for radical cystectomy by the treating physician, or the patient must refuse radical cystectomy, which is considered standard of carefor these patients. The reason for patients not to undergo cystectomy will be clearly documented. Objectives: Complete response at 25 weeks after registration for those with a CIS component; event-free survival at 18 months in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (Ta/T1/CIS)treated with atezolizumab. To estimate event-free survival at 18 months for the subset of patients with papillary cancer (Ta/T1). Progression-free survival, cystectomy-free survival,bladder cancer specific survival, overall survival in all patients. NCT Registration ID (from clinicaltrials.gov): NCT02844816 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: April 07, 2017 Closing Date: July 05, 2019 Chair: (Canada) Dr. Peter Black, Clinical Research Unit at Vancouver Coastal, (604) 875-5003, (Canada) Dr. Wassim Kassouf, The Research Institute of the McGill University, (514) 934-8246	Closed to Accrual
I223	A Phase II Study of Palbociclib, A CDK4/6 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer Read More Complexity Level: 1 Eligibility: Patients (>=18 years old, ECOG PS 0-1) must have histologically confirmed mCRPC with no evidence of small cell/neuroendocrine differentiation. Patients will be pre-screened for CCDN1 amplification and RB1 status. Clinically/radiologically documented disease (measurable or non-measurable). Evidence of biochemical and/or radiological disease progression in the setting of surgical or medical castration. Patients must have received prior hormonal treatment with at least one of abiraterone acetate, enzalutamide, ARN-509 TAK-700 and TOK-001. Prior anti-androgen therapy must have been discontinued >=28 days (>=42 days for bicalutamide) prior to registration. Maximum of one prior regimen of cytotoxic chemotherapy permitted. Prior immunotherapy, vaccines and oncolytic viruses permitted. Prior/concurrent CDK or mTOR inhibitors, strontium-89, systemic corticosteriods equivalent to prednisone >10 mg daily not allowed. Potent/strong CYP3A inhibitors/inducers not allowed. Objectives: PRIMARY - To assess the clinical benefit rate (CBR) of palbociclib in patients with metastatic, castration-resistant prostate cancer (mCRPC). SECONDARY - (1) To determine the effect of palbociclib on PSA decline and time to PSA progression; (2) To determine objective response as determined by RECIST 1.1 criteria; (3) To evaluate the safety and toxicity profile of palbociclib in mCRPC patients. EXPLORATORY - (1) To determine whether CCND1 gain/amplification in plasma cell-free DNA (cfDNA) (+/-RB1 wild type) is predictive of CBR to palbociclib; (2) To evaluate gene copy number variation and mutation profile of cfDNA in patients with mCRPC before and after treatment with palbociclib; (3) To identify potential predictive and prognostic blood-based RNA markers. NCT Registration ID (from clinicaltrials.gov): NCT02905318 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: February 09, 2017 Closing Date: December 13, 2021 Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746	Closed to Accrual
I232	A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer Read More Complexity Level: 2 Eligibility: Patients with histologically confirmed adenocarcinoma of the prostate that is castrate resistant. Must have disease progression either PSA, objective or both as well as surgical or medical castration with testosterone levels <50mg/dL. An available tissue block from primary or metastatic tumour as well as accessible disease suitable for fresh biopsy and consent to biopsy prior to treatment is required. Patients must have measurable disease per RECIST 1.1. Patients may have received prior treatment with docetaxel chemotherapy, tyrosine kinase or other targeted agents. Failure/progression on abiraterone and/or enzalutamide is required. Antiandrogens must have been discontinued for < 4 weeks prior to study entry (6 weeks for bicalutamide). No prior immunotherapy or vaccines, treatment with oncolytics viruses is permissible. No prior history of immunodeficiency, or use or immunosuppressive agents within 28 days of randomization. Objectives: Primary - To determine the objective response rate (RECIST 1.1 and irRECIST) in patients with metastatic castration resistant prostate cancer (mCRPC) treated with durvalumab alone or in combination with tremelimumab. Secondary - To determine the prostate-specific antigen (PSA) response rate as time to PSA progression; To evaluate time to objective disease progression; To evaluate the toxicity and tolerability of durvalumab alone or in combination with tremelimumab. Exploratory - To explore the utility of tissue and blood based biomarkers to select patients for treatment with durvalumab alone or in combination with tremelimumab. NCT Registration ID (from clinicaltrials.gov): NCT02788773 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: August 18, 2016 Closing Date: October 01, 2019 Chair: (Canada) Dr. Eric W. Winquist, London Regional Cancer Program, (519) 685-8261, (Canada) Dr. Sebastien Hotte, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64605	Closed to Accrual
I234A	A Phase II Study of AZD1775, A WEE1 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234 Read More Complexity Level: 1 Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234. Patients without history of hypersensitivity to AZD1775 or any of its excipients or who have not received treatment with drugs with a similar mechanism of action. Patients witout any factors that increase the risk of QTc prolongation or risk of arrhythmic events or mean resting corrected QT interval (QTc) <= 470 msec. Patients on drugs with a narrow therapeutic index which are substrates of BRCP, PGP, CYP2C19 or CYP1A2, inhibitors of PGP, and which cannot be discontinued or changed to alternative drugs are not eligible. Objectives: To determine the effect of AZD1775 on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of AZD1775 in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation. NCT Registration ID (from clinicaltrials.gov): NCT03385655 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: December 12, 2017 Closing Date: December 08, 2021 Chair: (Canada) Dr. Michael Kolinsky, Cross Cancer Institute, (780) 432-8762	Closed to Accrual
I234D	A Phase II Study of CFI-400945 Fumarate in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Read More Complexity Level: 1 Eligibility: Patients must meet the following criteria in addition to the eligibility criteria outlined in IND.234. All patients must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block. Objectives: Primary Objectives To determine the effect of CFI-400945 on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation. To evaluate the safety and toxicity profile of CFI-400945 in mCRPC patients. NCT Registration ID (from clinicaltrials.gov): NCT03385655 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: CCTG Led Trial Status: Closed to Accrual Activation Date: March 18, 2019 Closing Date: December 20, 2022	Closed to Accrual
PR17 (ANZUP 1304)	Randomised Phase III Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET Read More Complexity Level: 2 Eligibility: Men starting first line androgen deprivation therapy for metastatic adenocarcinoma of the prostate. Key eligibility criteria include metastatic prostate cancer, adequate organ function and ECOG performance status 0-2. Objectives: Primary endpoint: Overall survival NCT Registration ID (from clinicaltrials.gov): NCT02446405 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: February 02, 2015 Closing Date: March 24, 2017 Chair: (Canada) Dr. Scott North, Cross Cancer Institute, (780) 432-8762	Closed to Accrual
PRC3 (CALGB C90203)	A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer. Read More Complexity Level: 2 Eligibility: Patients with High-Risk, Clinically Localized Prostate Cancer. Objectives: PSA Free Survival 3 Years Post Op; Compare 5-year bPFS, Disease Progresssion; Disease Free Survival and Overall Survival; Difference in Pathologic Stage; Safety and Tolerability; Correlative Studies: Diet and lifestyle; Frozen Tissue and Paraffin Blocks for Biomarker Analyses, Expression Profiling, chromosomal Gain or Loss Analysis NCT Registration ID (from clinicaltrials.gov): NCT00430183 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: October 15, 2007 Closing Date: October 02, 2015 Chair: (Canada) Dr. Martin E. Gleave, Clinical Research Unit at Vancouver Coastal, (604) 875-4111	Closed to Accrual
PRC4 (ALLIANCE A031201)	Phase III Trial of Enzalutamide (NSC#766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer Read More Complexity Level: 2 Eligibility: Progressive castration-resistant metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features. Objectives: To compare the overall survival of patients with progressive metastatic castration-resistant prostate cancer treated with either enzalutamide only or enzalutamide with abiraterone and prednisone. To assess the toxicity profile and compare safety by treatment arm, to assess and compare post-treatment PSA declines by treatment arm, to compare radiographic progression free survival and objective response rate by treatment arm, to test for radiographic progression free survival treatment interaction in predicting overall survival, to assess pre- and post-treatment measures of tumor burden and bone activity using PET/CT and bone scintigraphy and correlate these measures with overall survival, and to develop and validate prognostic and predictive models of overall survival. NCT Registration ID (from clinicaltrials.gov): NCT01949337 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: October 27, 2014 Closing Date: August 31, 2016 Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746	Closed to Accrual
REC3 (SWOG S1500)	A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005],Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET) Read More Complexity Level: 2 Eligibility: Patients must have histologically or cytologically confirmed papillary renal cell carcinoma which is metastatic or locally advanced disease not amenable to surgical resection. They must also have measurable disease (RECIST), they may have received prior therapy (up to one prior systemic therapy for advanced or metastatic renal cell carcinoma or prior radiation therapy), have a Zubrod PS of 0-1, have adequate hematologic and hepatic function, and be 18 years of age or older. Patients must have tissue available and be willing to submit for central pathologic review. Objectives: Primary Objective: To compare progression-free survival (PFS) in patients with mPRCC treated with sunitinib to PFS in patients with mPRCC treated with MET kinase inhibitors. Secondary Objectives: a. To compare RECIST response rate (RR; defined as the combined rate of confirmed and unconfirmed PR and confirmed and unconfirmed CR) in patients with mPRCC treated with sunitinib to RR in patients treated with putative MET inhibitors. b. To compare overall survival (OS) in patients with mPRCC treated with sunitinib to OS in patients with mPRCC treated with putative MET inhibitors. c. To compare the safety profile of sunitinib and putative MET inhibitors in patients with mPRCC. Translational Objectives: To evaluate the prognostic and predictive value of MET mutations, MET copy number or other markers of MET signaling in patients with mPRCC treated with putative MET inhibitors NCT Registration ID (from clinicaltrials.gov): NCT02761057 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: July 27, 2016 Closing Date: December 15, 2019 Chair: (Canada) Dr. Daniel Heng, Tom Baker Cancer Centre, (403) 521-3166	Closed to Accrual
REC4 (ECOG-ACRIN EA8143)	A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC) Read More Complexity Level: 2 Eligibility: Patients with newly diagnosed higher risk RCC of any histology including sarcomatoid or unknown histology confirmed by biopsy for which radical or partial nephrectomay is planned. Patients must have no distant metastases, history of RCC within the past 5 years and have had no concurrent or prior systemic or local anti-cancer therapy for RCC. Paitents must be over the age of 18 and have no active or suspected autoimmune disease, no ongoing condition requireing systemic treatment with corticosteroids/other immunosuppressants and no history of severe hypersensitivity to a monoclonal antibody. Objectives: Primary Objective: To compare recurrence-free survival (RFS) between patients with locally advanced renal cell carcinoma randomly assigned to perioperative nivolumab in conjunction with radical or partial nephrectomy with patients randomized to surgery alone. Secondary Objectives: To evaluate for differences in RFS associated with perioperative nivolumab compared to surgery alone among patients with clear cell histology. To compare the overall survival between the two arms. To describe the safety and tolerability of perioperative nivolumab. NCT Registration ID (from clinicaltrials.gov): NCT03055013 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Closed to Accrual Activation Date: October 31, 2018 Closing Date: June 09, 2021 Chair: (Canada) Dr. Daniel Heng, Tom Baker Cancer Centre, (403) 521-3166	Closed to Accrual
BL1	A Clinical Trial on the Effects of Adjuvant Chemotherapy on Two Different Contemporary Treatments for Infiltrating Bladder Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 20, 1979 Closing Date: September 01, 1980	Permanently Closed
BL10 (4B951)	MVAC in Organ-Confined Bladder Cancer Based on p53 Status. Read More Eligibility: Patients who have undergone a radical cystectomy and bilateral pelvic lymphadenectomy Objectives: To compare the recurrence free and overall survival of those patients with alterations in the p53 gene who are treated with MVAC to patients with tumours demonstrating p53 alterations who are observed. To compare the recurrence free and overall survival prospectively of patients with tumours demonstrating alterations in p53 who are observed to patients with no p53 alterations who are also observed. To examine the expression of p53 and other genes, particularly RB, p21 and p16 involved in cell cycle regulation that may be involved in the response to chemotherapy. To study the association of p53 mutational gene status with p53 proteinexpression by IHC, outcome (recurrence-free and overall survival). NCT Registration ID (from clinicaltrials.gov): NCT00005047 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: December 22, 2003 Closing Date: March 28, 2006	Permanently Closed
BL11	A Phase III Study of Iressa? in Combination with Intravesical BCG versus Intravesical BCG Alone in High Risk Superficial Transitional Cell Carcinoma of the Bladder Read More Eligibility: Patients with high risk Ta, Tis or T1 superficial bladder cancer, who completed transurethral resection of all visible bladder lesions within 21 to 60 days prior to randomization, and without other evidence of metastasis. Objectives: Comparisons of time to treatment failure, complete response rate for patients with carcinoma in situ (Tis) at randomization, time to recurrence, time to progression, overall survival, adverse event and safety, and quality of life. Evaluate prognostic significance of tumour marker expression on the primary tumour and impact of therapy on tumour marker expression. NCT Registration ID (from clinicaltrials.gov): NCT00352079 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 12, 2006 Closing Date: December 04, 2008	Permanently Closed
BL2	The Prophylactic Use of Intravesical Mitomycin C in Recurrent Superficial Bladder Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: November 18, 1981 Closing Date: October 15, 1982	Permanently Closed
BL3	NCIC Trial of Pre-Operative (or Radical) Radiotherapy With Randomized Addition of Concurrent Cisplatin for Locally Advanced Transitional Cell Carcinoma of the Bladder Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: May 03, 1985 Closing Date: April 19, 1989	Permanently Closed
BL4 (E5886)	A Phase III Trial of Cisplan Alone or in Combination with Doxorubicin, Vinblastine and Methotrexate in Advanced Bladder Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: October 30, 1986 Closing Date: May 15, 1989	Permanently Closed
BL5 (BA06)	A Phase III Study of Primary Chemotherapy in Locally Advanced Transitional Cell Carcinoma of the Bladder Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: March 02, 1990 Closing Date: June 01, 1995	Permanently Closed
BL7 (30987)	Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients with Metastatic or Locally Advanced Urothelial Cancer without Prior Systemic Therapy Read More Eligibility: Patients with locally advanced and/or metastatic cell carcinoma of the urothelium who have not had prior systemic therapy. Patients must have histologically proven stage IV locally advanced disease (T4b, N0-N1) or metastatic ((N2N3 or M10 transitional cell carcinoma of the urothelium (pure or mixed) including bladder, urethra, ureter and renal pelvis. Patients should not be suitable for surgery or radiation with curative intent. However, patients whose pre-chemotherapy sites of disease are restricted to the primary or regional lymph node sites and who have had a major response to chemotherapy will be evaluated for post-chemotherapy surgical resection of residual cancer if the tumour has become resectable at the end of chemotherapy. Objectives: The primary objective of this trial is to compare two treatment groups, cisplatin/ gemcitabine and cisplatin/ gemcitabine/ paclitaxel, with respect to the duration of survival. Secondary objectives are to compare in the two treatment groups the: 1) duration of progression-free survival 2) response rates (RECIST) 3)duration of response. Also to compare and characterize the nature of the toxicity experienced in each arm. NCT Registration ID (from clinicaltrials.gov): NCT00022191 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: December 11, 2001 Closing Date: June 01, 2004	Permanently Closed
BL8 (30994)	Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients with pT3-pT4, and/or N+M0 Transitional Cell Carcinoma (TCC) of the Bladder. Read More Complexity Level: 2 Eligibility: Patients with histologically proven transitional cell carcinoma (TCC) of the bladder (pT2 incidental pT3 or pT4) and/or node positive (pN1-3) M0 TCC following radical cystectomy and lymphadenectomy. Lymph node dissection of 15 or more lymph nodes is recommended. Patients must be able to start chemotherapy within 90 days after surgery. Objectives: To compare the survival of patients with T3-T4 or N+ bladder cancer after radical cystectomy when treated with immediate adjuvant chemotherapy versus chemotherapy at relapse; to compare the progression-free survival. NCT Registration ID (from clinicaltrials.gov): NCT00028756 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: December 11, 2001 Closing Date: May 09, 2008	Permanently Closed
I111	A Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Hormone Refractory Prostate Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 12, 1998 Closing Date: January 22, 1999	Permanently Closed
I119	A Phase II Study of Troxacitabine in Patients With Advanced and/or Metastatic Renal Cell Carcinoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 16, 1999 Closing Date: March 21, 2000	Permanently Closed
I128	NCIC CTG Phase II Study of SCH66336 in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract Who Have Received Prior Chemotherapy Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 03, 1999 Closing Date: May 01, 2001	Permanently Closed
I140	A Randomized Phase II Study Of ZD1839 (Iressa) in Patients With Hormone Refractory Prostate Cancer Read More Eligibility: Prostate cancer patients with evidence of progression by rising PSA or progressive measurable disease on androgen ablative therapy; PSA > 20 ng/mL; chemo-naive; minimally symptomatic disease. Objectives: To determine the efficacy, and toxicity of two different doses of ZD1839 (250 mg or 500 mg) in patients with hormone refractory prostate cancer. Objective response where applicable, PSA response and duration of these responses, will be measured. NCT Registration ID (from clinicaltrials.gov): NCT00025116 NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 24, 2001 Closing Date: April 25, 2002	Permanently Closed
I143	A Phase II Study Of MG98 Given as a 2-Hour Twice Weekly Infusion in Patients With Advanced and/or Metastatic Renal Cell Carcinoma Read More Eligibility: Patients with recurrent or metastatic renal cell carcinoma. No prior chemotherapy or immunotherapy for advanced/recurrent disease. Clinically and/or radiologically documented unidimensionally measurable disease. Objectives: To evaluate the efficacy and safety of MG98 when given as a 2-hour IV infusion twice weekly for 3 out or every 4 weeks in patients with advanced and/or metastatic renal cell carcinoma. NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: May 01, 2001 Closing Date: May 10, 2002	Permanently Closed
I153	A Phase I Study of Combination Neoadjuvant Hormone Therapy and Weekly OGX-011 (Clusterin Antisense Oligonucleotide) Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer Read More Eligibility: Histologically confirmed adenocarcinoma of the prostate. No prior treatment. Must be a potential candidate for radical prostatectomy. Minimum 2 positive biopsies and at least one of the following: clinical stage T3; serum PSA > 10 ng/ml; Gleason score 7-10 or Gleason score 6 and >= 3 positive biopsies Objectives: To determine the toxicity and define the recommended phase II dose of OGX-011 administered days 1, 3, 5, 8, 15, 22 and 29 intravenously with neoadjuvant hormone therapy prior to radical prostatectomy. To determine the plasma pharmacokinetic profile To determine the tissue concentration of OGX-011 in radical prostatectomy specimens. To measure evidence of effect on clusterin expression in peripheral blood mononuclear cells and clusterin serum levels. To assess the effect of the combined hormone and OGX-011 therapy on com[plete response rates. To attempt to establish correlations between palsma and or prostate concentrations of OGX-011 with patient response or toxicity. NCT Registration ID (from clinicaltrials.gov): NCT00054106 Participation: Limited to one centre: BCCA-Vancouver NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: December 06, 2002 Closing Date: May 05, 2004	Permanently Closed
I161	A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma Read More Eligibility: Patients with histologically or cytologically documented renal cell cancer that is locally recurrent or metastatic. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. No prior systemic chemotherapy regimens. Previous interferon permitted > 3 months prior to study entry. No immunotherapy for advanced/recurrent disease. No gene therapy. Known HIV-positive patients are not permitted nor patients with known glucose-6 phosphate dehydrogenase deficiency. Objectives: To assess the efficacy (objective response rate) of Triapine given as a 2-hour IV infusion for 4 consecutive days every other week to patients with recurrent/ metastatic renal cell cancer who have received no prior systemic therapy for recurrence. To determine adverse events and tolerability of Triapine in this patient population. To describe time to disease progression and overall patient survival. NCT Registration ID (from clinicaltrials.gov): NCT00075660 NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 16, 2004 Closing Date: April 05, 2005	Permanently Closed
I165	A Randomized Phase II Study Of OGX-011 In Combination With Docetaxel And Prednisone Or Docetaxel And Prednisone Alone In Patients With Metastatic Hormone Refractory Prostate Cancer. Read More Eligibility: Histologically or cytologically diagnosed prostate cancer with documented evidence of progression by rising PSA (>5 ng/mL at baseline). Patients must have metastatic or locally recurrent disease for which no curative therapy exists and for which systemic chemotherapy is indicated due to progression while receiving androgen ablative therapy. No prior chemotherapy except estramustine. Prior hormone therapy permitted but must be refractory and discontinued > 4 weeks (6 wks for bicalutamide). Prior radiation permitted if > 4 weeks. ECOG 0, 1, 2. Adequate organ function. No pre-existing neuropathy >= grade 2 or therapeutic anti-coagulation. Objectives: To determine the efficacy, as measured by PSA response and duration of response, of weekly OGX-011 administered intravenously in combination with q 3 weekly docetaxel and prednisone, or docetaxel and prednisone in patients with HRPC. To determine objective response and duration in those with measurable disease at baseline. To determine tolerability and toxicity when given in this schedule. To measure evidence of OGX-011 and docetaxel or docetaxel effect on serum clusterin levels. To describe time to progression and overall patient survival for both cohorts. NCT Registration ID (from clinicaltrials.gov): NCT00258388 Participation: Limited to selected centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 27, 2005 Closing Date: December 21, 2006	Permanently Closed
I167	Phase II Study of BAY 43-9006 (NSC 724772) in Patients With Hormone Refractory Prostate Cancer Read More Eligibility: Patients with histologically or cytologically diagnosed prostate cancer that is advanced and non-curable with standard therapy. PSA progression with PSA>10 ng/mL at study entry. Primary tumour available for immunohistochemistry. No prior chemotherapy. Minimally symptomatic disease. Objectives: To determine PSA response rate. To determine objective response rate and duration of response as measured by RECIST. To determine the tolerability and toxicity of BAY 43-9006 given to this patient population. To describe time to treatment failure and overall patient survival. To correlate the relationship between tumour markers and patients with response and with non-progression. NCT Registration ID (from clinicaltrials.gov): NCT00093457 Participation: Limited to invited centres only. NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 21, 2004 Closing Date: December 20, 2005	Permanently Closed
I195	A Phase II Study of SB939 in Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer Read More Complexity Level: 2 Eligibility: Patients with a histological diagnosis of metastatic and/or locally recurrent castration resistant adenocarcinoma of the prostate. Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry. PSA >= 5 ng/mL at study entry. Up to 1 prior chemotherapy regimen is permitted. ECOG 0 or 1. Adequate cardiac function and acceptable end-organ function. Objectives: 1.1 The primary objective of this study is to determine the efficacy (as measured by PSA response and progression free survival) of SB939 when given orally every other day 3 times a week, in patients with castration resistant prostate cancer, who have received 0-1 prior chemotherapy regimens. 1.2 To determine objective response and response duration in patients with measurable disease at baseline. 1.3 To determine the tolerability and toxicity of SB939 in this population. 1.4 Enumeration of Circulating Tumour Cells (CTC) at baseline and after 6 weeks (and 12 weeks if patient is still on study treatment) using two methodologies. 1.5 To explore potential molecular factors predictive of response by assessment of archival prostate tumour tissue. 1.6 To explore the utility of ERG and PTEN expression on circulating tumour cells as a potential prognostic and predictive marker for response to SB939. 1.7 To describe time to PSA and time to objective progression in patients treated with SB939. NCT Registration ID (from clinicaltrials.gov): NCT01075308 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 10, 2010 Closing Date: November 04, 2011	Permanently Closed
I205	A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer (CRPC). Read More Complexity Level: 2 Eligibility: Androgen ablation must include either medical or surgical castration. If the patient is receiving medical androgen ablation, a castrate level of testosterone (< 1.7 nmol/L) must be present. Patients must have metastatic or locally recurrent disease, for which no curative therapy exists and for which systemic therapy is indicated due to progression following castration. Either:PSA Progression: A rising PSA, while receiving androgen ablative therapy, with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of >= 5 ng/ml and must be performed no longer than 7 days prior to trial registration.OR Radiological Progression. The PSA must be >=5 ng/ml at the time of study entry. ECOG performance of 0, 1 or 2; Age > 18 years of age. All patients must have formalin fixed paraffin embedded tissue. Presence of clinically and/or radiologically documented disease. Objectives: To determine the efficacy of PX-866 when given orally daily in patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease.To determine the tolerability and toxicity. of PX-866 in this population. To investigate additional potential measures of efficacy including: PSA response rate, Objective response rate, Change in circulating tumour cell number during treatment. To explore potential molecular factors predictive of response by assessment of archival prostate tumour tissue and baseline circulating tumour cells. In selected participating centres, to determine evidence of effect on PI3K activation pre- and post administration of PX-866 in platelets NCT Registration ID (from clinicaltrials.gov): NCT01331083 NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 04, 2011 Closing Date: January 10, 2014	Permanently Closed
I209	A Randomized Phase II Study of Reolysin in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Castration Resistant Prostate Cancer Read More Complexity Level: 2 Eligibility: Patients with a histological diagnosis of metastatic and/or locally recurrent castration resistant adenocarcinoma of the prostate. Tumour block available. Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry. PSA >= 5 ng/mL at study entry. No prior chemotherapy for recurrent/metastatic disease. No prior docetaxel unless given adjuvantly and >= 12 months prior to enrollment. ECOG 0, 1 or 2. Adequate end-organ function. Objectives: 1. To evaluate efficacy which will be based on the lack of disease progression measured at 12 weeks. 2a. To determine the tolerability and toxicity of Reolysin and docetaxel when given in combination. 2b. To investigate additional potential measures of efficacy including CTC status, CTC conversion rate, change in PSA levels, Objective response rate and effect of both treatments on overall survival. 2c. Explore potential molecular factors predictive of response in archival tumour and baseline CTCs. NCT Registration ID (from clinicaltrials.gov): NCT01619813 Participation: Limited to invited centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 11, 2012 Closing Date: September 25, 2015	Permanently Closed
I24	NCIC CTG Phase II Study of Deoxycoformycin in Renal Cell Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: September 06, 1985 Closing Date: November 26, 1986	Permanently Closed
I38	NCIC CTG Phase II Study of TNF in Renal Cell Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 01, 1988 Closing Date: September 01, 1989	Permanently Closed
I4	NCIC CTG Phase II Study of Lonidamine in Hypernephroma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 01, 1982 Closing Date: May 05, 1984	Permanently Closed
I46	NCIC CTG Phase II Study of LY186641 in Patients With Renal Cell Carcinoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: October 25, 1989 Closing Date: May 11, 1990	Permanently Closed
I49	NCIC CTG Phase II Study of Gemcitabine in Renal Cell Carcinoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 19, 1990 Closing Date: November 30, 1990	Permanently Closed
I6	NCIC CTG Phase II Study of Interferon in Renal Cell Cancer Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: November 01, 1983 Closing Date: September 20, 1984	Permanently Closed
I70	NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Renal Cell Carcinoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 24, 1992 Closing Date: February 03, 1993	Permanently Closed
I88	A Phase I/II Study of 9-Cis-Retinoic Acid (LGD1057) and Interferon a-2b (INTRON A) in Patients With Recurrent or Metastatic Renal Cell Carcinoma Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 03, 1995 Closing Date: April 29, 1997	Permanently Closed
I95	NCIC CTG Phase II Study of Gemcitabine/Cisplatin in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: August 06, 1996 Closing Date: October 03, 1997	Permanently Closed
PNC1 (ECOG-ACRIN EA8134)	InPACT: International Penile Advanced Cancer Trial Read More Complexity Level: 2 Eligibility: (1) Male, aged 18 years or older, (2) Histologically-proven squamous cell carcinoma of the penis. (3) Stage: any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0, OR; any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0 OR; any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0, (4) Measurable disease as determined by RECIST (version 1.1) criteria, (5)Performance Status ECOG 0, 1 or 2, (6) Patient is fit to receive the randomisation options for which he is being considered. (7) adequate hematology, biochemistry, liver function, renal function tests, and patient must be suitable for randomization options. EXCLUSION: Pure verrucous carcinoma of the penis; Non-squamous malignancy of the penis; Squamous carcinoma of the urethra; Stage M1; Previous chemotherapy or chemoradiotherapy outside of the InPACT trial. Objectives: Primary objective: (1) (a) Is there a role for neoadjuvant therapy and, if so, (b) does CT or CRT produce superior outcomes (2) What is the additional survival benefit of PLND given after neoadjuvant s or with adjuvant CRT of the pelvic nodes over and above that of chemoradiotherapy alone in patients at high risk of recurrence following ILND? Secondary objectives: In InPACT-neoadjuvant: (a) Can neoadjuvant therapy prior to surgery (ILND) reduce recurrence rates? (b) Which is the more active of neoadjuvant CT or neoadjuvant CRT? (c) What is the op/post-op complication rate following neoadjuvant therapy of both types? (c) Is neoadjuvant CRT feasible in this setting? In InPACT-pelvis: (a) What is the rate of additional complications for the combination of PLND and CRT? Exploratory objectives: (a) What is the relationship between HPV status and outcome for all groups studied? (b) What is the impact on QOL of (sequential) treatments studied? NCT Registration ID (from clinicaltrials.gov): NCT02305654 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: May 30, 2018 Closing Date: December 02, 2022	Permanently Closed
PR1	Hormonal Therapy versus Radiotherapy for the Treatment of Clinical Stage C and D Carcinoma of the Prostate Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: April 01, 1979 Closing Date: May 26, 1981	Permanently Closed
PR10 (Z0070)	Randomized Trial of Radical Prostatectomy versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer Read More Eligibility: Patients must have a PSA of < 10 ng/ml. Patients must have histologically proven clinical stage T1c (usually impalpable) or T2a (unilaterally abnormality, papable or visible on TRUS), N0, M0 adenocarcinoma of the prostate, diagnosed within 120 days prior to registration on this study. Note: bilateral palpable disease is not allowed. Objectives: To ascertain whether patients assigned to receive brachytherapy have equal or better overall survival as compared to patients randomized to receive radical prostatectomy. To compare the two treatment arms with respect to: metastasis-free survival, the probability of survival without symptoms, side effects from the intervention and Quality of Life addressed in the companion study. NCT Registration ID (from clinicaltrials.gov): NCT00023686 Participation: Limited to centres with a current CPA/FWA # NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: February 19, 2002 Closing Date: April 09, 2004	Permanently Closed
PR10C (Z0071)	Health-Related Quality of Life in Patients With Low Risk, Localized Prostate Cancer Randomized to Radical Prostatectomy or Brachytherapy Read More Eligibility: Must be randomized to PR.10 Objectives: To obtain quality of life information. NCT Registration ID (from clinicaltrials.gov): NCT00052481 Participation: Patients randomized to PR.10 NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: September 19, 2003 Closing Date: April 09, 2004	Permanently Closed
PR11	A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed with Favourable Risk Prostate Cancer (START) Read More Complexity Level: 2 Eligibility: Histologically confirmed adenocarcinoma of the prostate that is negative for metastasis. Patient is a suitable candidate for radical prostatectomy or radiotherapy. No previous treatment for prostate cancer for greater than 6 months. Patient has been classified as favourable risk as defined by the following: clinical stage T1b, T1c, T2a or T2b, surgical Gleason score <= 6, PSA <= 10.0 ng/ml. For more information, please view our Patient Educational Video at the following web link: http://smaug/trials/start/start.html Objectives: To compare disease specific survival in patients with favourable risk prostate cancer treated with radical prostatectomy or radical radiotherapy at the time of initial diagnosis to active surveillance and selective intervention based on pre-specified biochemical, histological or clinical criteria. NCT Registration ID (from clinicaltrials.gov): NCT00499174 Participation: Not limited NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: June 15, 2007 Closing Date: May 13, 2011	Permanently Closed
PR12	Phase III Study of Neoadjuvant Docetaxel And Androgen Suppression Plus Radiation Therapy Versus Androgen Suppression Alone Plus Radiation Therapy For High-Risk Localized Adenocarcinoma Of The Prostate (DART) Read More Eligibility: Patients with histologically proven, localized (NO, M0) adenocarcinoma of the prostate with adverse prognostic features which are considered to be high risk for recurrence based on the presence of at least one of the following features: T stage > or = to 3a, Gleason Score > or = 8 or presenting PSA>20 Objectives: The primary objective is to compare disease free survival rates in men treated with androgen suppression therapy and radiation therapy followed by androgen suppression therapy with or without neoadjuvant docetaxel. Secondary objectives include overall survival, degree of PSA suppression prior to radiation therapy and Quality of Life. NCT Registration ID (from clinicaltrials.gov): NCT00651326 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: March 03, 2008 Closing Date: November 12, 2009	Permanently Closed
PR13 (MRC PR10)	RADICALS: Radiotherapy and Androgen Deprivation In Combination After Local Surgery Read More Complexity Level: 2 Eligibility: Men who have undergone radical prostatectomy for prostateic adenocarcinoma within 3 months. RT Timing Randomization: Post-opterative serum PSA less than 0.4 ng/mL. Uncertainty in the opinon of the physician and patient regarding the need for immediate post-operative RT. Hormone Duration Randomization: Post-opterative serum PSA less than 10 ng/mL. Patient is due to receive post-operative RT either adjuvant or salvage. Objectives: Disease free survival; Freedom from treatment failure; Clinical progression-free survival; Overall survival; Non-protocol hormone therapy Quality of life; Treatment toxicity NCT Registration ID (from clinicaltrials.gov): NCT00541047 Participation: Open to member centres NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: September 27, 2007 Closing Date: December 30, 2016	Permanently Closed
PR2 (8794)	Treatment of Pathologic Stage C Carcinoma of the Prostate With Adjuvant Radiotherapy Read More NCT Registration ID (from clinicaltrials.gov): no NCT NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: February 22, 1990 Closing Date: January 01, 1997	Permanently Closed
PR3 (PR3)	Intergroup Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation In Clinical Adenocarcinoma Of The Prostate Read More Eligibility: Patients with adenocarcinoma of the prostate who have performance status of 0-2, adequate blood counts and liver and kidney function, and no contraindication to pelvic radiotherapy. Objectives: To evaluate any benefit from the addition of radiation therapy to the treatment of the patients with cancer of the prostate who are receiving hormonal therapy in terms of overall survival, time to progression, symptomatic local control, and quality of life. NCT Registration ID (from clinicaltrials.gov): NCT00002633 Participation: Limited to North America centres with current CPA/FWA#; all MRC - UK centres. NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: February 08, 1995 Closing Date: August 31, 2005	Permanently Closed
PR5 (PR5)	A Randomized Trial of Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer Read More NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: February 14, 1995 Closing Date: September 15, 1998	Permanently Closed
PR6	Randomized Placebo-Controlled Trial of Mitoxantrone/Prednisone and Clodronate versus Mitoxantrone/Prednisone Alone in Patients with Hormone Refractory Metastatic Prostate Cancer and Pain Read More NCT Registration ID (from clinicaltrials.gov): NCT00003232 NCI US Affiliation: No Clinical Trials Application (Canada): Yes Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: November 24, 1997 Closing Date: May 14, 2001	Permanently Closed
PR7 (PR7)	A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer Read More Complexity Level: 2 Eligibility: Patients who completed radiotherapy to the prostate more than a year ago and who have a rising PSA > 3 ng/ml and higher than the lowest level since the end of radiotherapy without other evidence of metastasis. Objectives: Comparisons of overall survival, time to the development of hormone resistance, quality of life, serum cholesterol and HDL/LDL levels. Evaluate duration of treatment and non-treatment intervals, time to testosterone recovery and time to recovery of potency. NCT Registration ID (from clinicaltrials.gov): NCT00003653 Participation: Limited to centres with current CPA #. NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: January 05, 1999 Closing Date: November 30, 2005	Permanently Closed
PR8 (SWOG S9346)	Phase III Study of Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer. Read More Complexity Level: 2 Eligibility: Patients with histologically or cytologically confirmed adenocarcinoma of the prostate, clinical stage D2 as evidenced by soft tissue and/ or bony metastases. Objectives: To compare survival and quality of life in patients randomized to either intermittent or continuous combined androgen deprivation therapy (CAD). NCT Registration ID (from clinicaltrials.gov): NCT00002651 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: October 19, 1998 Closing Date: August 31, 2008	Permanently Closed
PR9 (P-0011)	Phase III Clinical Trial for PT3 and/or Margin Positive Prostate Carcinoma Following Radical Prostatectomy Read More Eligibility: Patients will have pathologic stage T3N0M0 prostate cancer at high-risk for PSA relapse as determined by GS > 7 and one or more of the following: 1) preoperative PSA > 10 ng/ml; 2) positive surgical margins; 3) seminal vesicle invasion. If Gleason score < 7, then two or more of the above factors. Patients who have negative LN status by lymph node sampling or LN dissection will be eligible. If pathologic LN status is unknown, the risk of involvement must be less than 5 % as determined by the Roach formula. Objectives: To test, in a randomized study, if the addition of androgen suppression to radiation therapy in patients with unfavorable pathologic stage pT3N0M0 prostate cancer leads to better outcome than each used separately. The endpoints will be overall survival, disease-free survival, freedom from distant metastases, and freedom from PSA failure. To compare the qualitative and quantitative toxicities of patients with pT3N0M0 prostate cancer treated adjuvantly with androgen suppression and radiation therapy to that of adjuvant radiation therapy or androgen suppression alone. NCT Registration ID (from clinicaltrials.gov): NCT00023829 Participation: Limited to centres with a current CPA/FWA # NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: February 25, 2004 Closing Date: May 07, 2004	Permanently Closed
PRC2 (CALGB C90202)	A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone Read More Complexity Level: 2 Eligibility: 1) Histologic documentation of prostate adenocarcinoma. 2) At least one bone metastasis by radiographic imaging 3) While on this study, patients must receive androgen deprivation therapy (ADT) for treatment of prostate cancer. 4) No prior treatement with bisphosphonates. 5) No prior treatment with radiation and hormones as sepcified in section 5.4 of the protocol. 6) ECOG (CTC) performance status 0-2. 7) Min. Age 18. 8) Baseline laboratory data should fall within protocol required limits. Objectives: Primary objective: To determine whether treatment with zoledronic acid at the time of initiation of androgen deprivation therapy for metastatic prostate cancer will delay the time to first skeletal related event. Secondary objective: To determine whether treatment with zoledronic acid will decrease the proportion of men with one or more vertebral fractures at two years compared to placebo in men receiving androgen deprivation therapy for metastatic prostate cancer. NCT Registration ID (from clinicaltrials.gov): NCT00079001 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): No Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: February 07, 2006 Closing Date: April 02, 2012	Permanently Closed
PRP1	A Double-Blind, Placebo-Controlled, Randomized Study of Combination Vitamin E, Selenium and Soy Protein Product in Subjects With High Grade Prostatic Intraepithelial Neoplasia Read More Eligibility: Documented high grade prostatic intraepithelial neoplasia (HGPIN) confirmed by the central reference pathologist. Two prostate biopsies performed within 18 months of randomization with the most recent within 6 months of randomization. Both biopsies must be negative for invasive prostate cancer. Objectives: To compare disease free survival, changes in serum PSA, oxidative biomarkers and hormone levels with nutrient supplement, containing vitamin E, selenium and soy protein, or placebo. To determine the association between prostate cancer development and exposure to various hypothesized risk factor for prostate cancer and to evaluate the safety of the treatment. NCT Registration ID (from clinicaltrials.gov): NCT00064194 Participation: Not limited NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: November 28, 2001 Closing Date: July 23, 2004	Permanently Closed
PRP1B	An Investigation of Molecular and Genetic Risk Factors Associated With Development of Prostate Cancer in Subjects With High Grade Prostatic Intraepithelial Neoplasia Treated With Placebo or Combination Vitamin E, Selenium and Soy Protein Product Read More Eligibility: Subjects who have met the eligibility criteria for and were previously enrolled in the NCIC CTG PRP.1 study: A double-blind, placebo-controlled, randomized study of combination vitamin E, selenium and soy protein product in subjects with high grade prostatic intraepithelial neoplasia. Objectives: To determine if molecular, genetic and immunohistochemical markers are associated with progression from high grade PIN to cancer. To determine if molecular or immunohistochemistry changes can occur in PIN among men treated with combination vitamin E, selenium and soy compared to placebo. To determine if cancers that arise within the PRP.1 study differ in terms of their proliferative capacity as measured by nuclear factor kappa B, p27 and ki-67, and to bank biopsy material, serum and DNA for future studies. NCT Registration ID (from clinicaltrials.gov): no NCT Participation: Limited to subjects enrolled on the PRP.1 study. NCI US Affiliation: No Clinical Trials Application (Canada): No Coordination: NCIC CTG Led Trial Status: Permanently Closed Activation Date: July 29, 2005 Closing Date: April 17, 2009	Permanently Closed
REC1 (CALGB C90206)	A Phase III Trial of Interferon-Alpha (IFNA) or IFNA Plus Bevacizumab in Advanced Renal Cell Cancer Read More Complexity Level: 2 Eligibility: Patients with advanced renal cell cancer. NCT Registration ID (from clinicaltrials.gov): NCT00072046 Participation: Open to member centres NCI US Affiliation: Yes Clinical Trials Application (Canada): Yes Coordination: Intergroup Led Trial Status: Permanently Closed Activation Date: April 23, 2004 Closing Date: July 01, 2005	Permanently Closed

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