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BLC6 (ALLIANCE A032103)

MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of Adjuvant Therapy in Urothelial Cancer

Testing the role of DNA released from tumor cells into the blood in guiding the use of immunotherapy after surgical removal of the bladder for bladder cancer treatment.


Complexity Level: 2

Eligibility: Pre-registration: • Histologically confirmed urothelial cancer of the bladder • Radical cystectomy ≥ 3 weeks, but ≤ 12 weeks prior to pre-registration • No evidence of residual cancer or metastases after surgery (imaging required prior to registration) • Available tumor tissue for “central” Signatera testing to be submitted after pre-registration • No active autoimmune disease or history of autoimmune disease that may recur • No current or history of pneumonitis or myocarditis • No known active Hepatitis B or C • No postoperative/adjuvant systemic therapy or radiation • No prior treatment with any PD-1 or PD-L1 axis inhibitors. • Age ≥18 years; Registration: • Radical cystectomy ≤ 18 weeks prior to registration. • ctDNA Signatera assay result based on test performed as part of “central testing” after pre-registration to A032103. • Disease-free status defined as no measurable disease by RECIST 1.1 within 60 days prior to registration

Objectives: Co-primary objectives: 1) To compare the ctDNA clearance proportion [i.e., ctDNA (+) → ctDNA (-)] at 12 weeks in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 2 portion). 2) To compare overall survival in patients enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatlimab (phase 3 portion). 3) To compare disease-free survival in patients enrolled in Cohort B randomized to immediate treatment with nivolumab to those randomized to surveillance with subsequent treatment with nivolumab only upon converting to ctDNA(+)

NCT Registration ID (from clinicaltrials.gov): NCT05987241
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: November 21, 2024

Chair: (Canada) Dr. Bernhard Eigl, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2707


Open to Accrual
PR24 (PR.24)

Androgen Suppression Combined with Elective Nodal Irradiation and Dose Escalated Prostate Treatment: A Non-Inferiority, Phase III Randomized Controlled Trial of Stereotactic Body Radiation Therapy versus Brachytherapy Boost in Patients with Unfavourable Risk Localized Prostate Cancer (ASCENDE-SBRT)

The purpose of this study is to compare two types of radiation therapy to treat unfavourable-risk non-metastatic prostate cancer. This study is being done because we want to find out if hypofractionated radiation therapy (radiation given over a shorter period of time) using a high precision externally delivered technique known as SBRT is as effective in controlling prostate cancer as conventional external radiation therapy given with a brachytherapy boost (which involves radiation sources inserted directly into your prostate), and to know if it has fewer side effects and better quality-of-life.


Complexity Level: 2

Eligibility: (1) Male, aged 18 years or older, (2) recent histologically confirmed prostate cancer with no evidence of metastases, (3) unfavourable-risk PC defined as NCCN unfavourable-intermediate risk, high risk and very-high risk, (4) ECOG PS 0-2, (5) medically suitable for all treatment options (including brachytherapy), (6) must be willing to take precautions to prevent pregnancy while on study. EXCLUSIONS: (1) Prior pelvic RT, (2) prior chemotherapy, PARPi, radioligand or other investigational drugs for prostate cancer, (3) contraindication to radical prostate RT, (4) anticoagulant medication and/or prior or current bleeding diathesis, (5) urinary function defined as IPSS > 20, (6) prior stem vaporization, TURP, prostatectomy (simple or radical), or any ablative therapy to the prostate, (7) prostate volume > 60cc before start of ADT, (8) evidence of castrate resistance (defined as a rising PSA > 3ng/ml while testosterone is <3.0nmol/l), (9) hip prostesis.

Objectives: PRIMARY: To compare the progression-free survival (PFS) of SBRT versus brachytherapy boost defined as biochemical failure (PSA nadir + 2ng/ml), initiation of salvage therapy, biopsy-proven recurrent disease, metastasis diagnosed by conventional imaging , or death. SECONDARY: To evaluate both treatment strategies with respect to safety and tolerability, PSA response rate at 4 years, metastasis-free survival, cause-specific survival, overall survival, patient-reported outcomes, and economic outcomes. TERTIARY: 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): NCT06235697
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: March 11, 2024

Chair: (Canada) Dr. Douglas Andrew Loblaw, Odette Cancer Centre, (416) 480-4806


Open to Accrual
PR25

A Randomized Phase III Trial Investigating Platinum and Taxane Chemotherapy in Metastatic Castration Resistant Prostate Cancer Patients with Alterations in DNA Damage Response Genes (OPTION-DDR)

The purpose of this trial is to determine the effect of adding carboplatin, a well-studied chemotherapy drug used to treat many kinds of cancer, to the standard treatment regimen of pariticpants with advanced prostate cancer who also have alterations in genes that help repair damaged DNA. Carboplatin is known to be effective in treating other cancer types with these mutations, and the researchers want to know if this applies to prostate cancer as well. The researchers also want to know if there are any alterations that can predict who would benefit from adding carboplatin. The toxicity of adding carboplatin will be evaluated as well.


Complexity Level: 2

Eligibility: Patients with a histological diagnosis of adenocarcinoma of the prostate with documented presence of metastatic disease. Participants must have received prior treatment with abiraterone, enzalutamide, apalutamide, or darolutamide, and have germline or somatic alterations in one or more of BRCA1, BRCA2, ATM, ATR, BRIP1, BARD1, CDK12, CHEK1, CHEK2, ERCC2, FANCA, FANCC, FANCD2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD54L. Medical or surgical castration is also required, along with a life expectancy greater than 12 weeks.

Objectives: Primary: Overall survival. Secondary: Radiographic progression-free survival; PSA response; Objective soft tissue response; Frequency and severity of adverse events; Paticipant-reported QoL. Tertiary: Overall survival across ethnic groups; Overall survival across different DDR gene alterations; DDR gene alteration patterns across ethnic groups.

NCT Registration ID (from clinicaltrials.gov): NCT06439225
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: October 08, 2024

Chair: (Canada) Dr. Michael Kolinsky, Cross Cancer Institute, (780) 432-8762


Open to Accrual
PR26 (PR.26)

A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients with Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response (TRIPLE-SWITCH)

The purpose of this trial is to compare overall survival in those with metastatic castration sensitive prostate cancer (mCSPC) who have a suboptimal PSA and are receiving standard of care ADT + ARPI with those who receive standard of care ADT + ARPI plus docetaxel chemotherapy. This study is being done because we want to find out if the addition of docetaxel chemotherapy to standard of care ADT + ARPI increases overall survival.


Complexity Level: 2

Eligibility: Histologically/cytologically confirmed adenocarcinoma of the prostate. Must have metastatic disease confirmed by conventional imaging (bone scan and/or computed tomography (CT) or by PET-PSMA scan only if CT component is of diagnostic quality. Patients must have received ADT for mCSPC for at least 6 months and no greater than 12 months at time of enrollment and ARPI (e.g. abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for at least 4 months at time of enrollment. Must have PSA of ≥5.0 ng/ml (5.0 ug/L) prior to commencement of ADT. Must have serum testosterone < 1.7 nmol/L or 50 ng/dL. Patients must have adequate hepatic, renal, and bone marrow function. Patient must be male (assigned male at birth) ≥18 years of age.

Objectives: PRIMARY: To compare overall survival (OS) in participants with mCSPC who are receiving standard of care ADT + ARPI and have suboptimal PSA response with those who receive standard of care ADT + ARPI plus docetaxel chemotherapy. SECONDARY: To compare both arms with respect to: (1) PSA progression (2) PSA response (3) PSA kinetics (4) Clinical progression free survival. TERTIARY: (1) To determine if detection and/or quantification of ctDNA can be a potentially useful biomarker in addition to PSA for prognostication, prediction of docetaxel benefit, and whether somatic alterations detected in ctDNA can clarify mechanisms of resistance to (chemo)-hormonal therapy (2) To explore OS by study arm using high- vs. low-volume mCSPC, ethnic or cultural origin, date of commencement of ADT, and molecular characterization of copy loss, inactivating mutations, structural rearrangements, and status of DNA-damage repair genes.

NCT Registration ID (from clinicaltrials.gov): NCT06592924
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: January 30, 2025

Chair: (Canada) Dr. Michael Ong, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 75051, (USA) Dr. Alexandra Sokolova, Oregon Health and Science University


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


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]


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, adherence) 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
GCC1 (SWOG S1823)

A Prospective Observational Cohort Study to Assess miRNA 371 for Outcome Prediction in Patients with Newly Diagnosed Germ Cell Tumours


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: Closed to Accrual
Activation Date: August 27, 2020 Closing Date: May 20, 2024

Chair: (Canada) Dr. Lucia Nappi, BCCA - Vancouver Cancer Centre, (604) 877-6000


Closed to Accrual
I223

A Phase II Study of Palbociclib, A CDK4/6 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer


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
I234

Prostate Cancer Biomarker Enrichment and Treatment Selection (PC_BETS) Study - Master Screening Protocol


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: Closed to Accrual
Activation Date: December 12, 2017 Closing Date: February 27, 2024

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


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


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
I234B

A Phase II Study of Savolitinib, A CMET Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234


Complexity Level: 1

Eligibility: Patients must meet the following criteria in addition to the eligibility 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: Closed to Accrual
Activation Date: December 12, 2017 Closing Date: February 27, 2024

Chair: (Canada) Dr. Som Mukherjee, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64605


Closed 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


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: Closed to Accrual
Activation Date: December 12, 2017 Closing Date: February 27, 2024

Chair: (Canada) Dr. Michael Ong, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 75051


Closed to Accrual
I234D

A Phase II Study of CFI-400945 Fumarate in Metastatic Castration-Resistant Prostate Cancer (mCRPC)


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
I234E

A Phase II Study of Ipatasertib in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients with PI3K Pathway Alterations in Circulating Tumour DNA (ctDNA)


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: Closed to Accrual
Activation Date: December 27, 2019 Closing Date: February 27, 2024

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Closed to Accrual
I234F

A Phase II Study of Durvalumab and Tremelimumab in Metastatic Castration-Resistant Prostate Cancer


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: Closed to Accrual
Activation Date: December 27, 2019 Closing Date: February 27, 2024

Chair: (Canada) Dr. Sebastien Hotte, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64605


Closed to Accrual
I234G

A Phase II Study of Carboplatin in Patients with Metastatic Castration-Resistant Prostate Cancer


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: Closed to Accrual
Activation Date: June 10, 2020 Closing Date: February 27, 2024

Closed to Accrual
PR17 (ANZUP 1304)

Randomised Phase III Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET


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
PR19

A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer


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: Closed to Accrual
Activation Date: November 04, 2016 Closing Date: April 10, 2025

Chair: (Canada) Dr. Eric Vigneault, CHUQ - Hotel Dieu de Quebec, (418) 691-5264, (Canada) Dr. Gerard Morton, Odette Cancer Centre, (416) 480-6165


Closed to Accrual
PR20

A Randomized Phase III Trial of Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer [PLATON]


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: Closed to Accrual
Activation Date: April 18, 2019 Closing Date: October 17, 2024

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


Closed 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


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: Closed to Accrual
Activation Date: December 17, 2020 Closing Date: January 16, 2024

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


Closed 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


Complexity Level: 2

Eligibility: Men with either very high-risk localized 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 survival; time to subsequent hormonal therapy; time to castration-resistance; frequency and severity of adverse events; health-related QoL; fear of cancer 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: Closed to Accrual
Activation Date: November 27, 2020 Closing Date: July 14, 2023

Chair: (Canada) Dr. M. Tamim Niazi, The Jewish General Hospital, (514) 340-8288


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.


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


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
REC4 (ECOG-ACRIN EA8143)

A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)


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
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


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: Permanently Closed
Activation Date: January 15, 2014 Closing Date: February 15, 2017

Permanently Closed
BLC4 (SWOG S1605)

Phase II Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder Cancer


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: Permanently Closed
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


Permanently Closed
I232

A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer


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: Permanently Closed
Activation Date: August 18, 2016 Closing Date: October 01, 2019

Permanently Closed