PR21

PR21 Details
Status: Closed
Activation Date: 2020DEC17
Closing Date: 2024JAN16
Phase: II

Description: A Randomized Phase II Study of 177Lu-PSMA-617 vs Docetaxel in Patients with Metastatic Castration-Resistant Prostate Cancer and PSMA-Positive Disease

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

Objective: (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.

Participation: Open to member centres

Lay Description: 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.

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Hide Tissue Samples

Disease Site	Trial Code	Patients Accrued	Patients - Blocks	Patients - Slides	Patients - Blocks and/or Slides
GENITO-URINARY	PR21	224	0	0	0

Hide TMA Samples

(Core size is 0.6 mm)

Disease Site	Trial Code	Patients Accrued	TMA Blocks	Patients on TMA Blocks
GENITO-URINARY	PR21	224	0	0

Hide Fluid Samples

Disease Site	Trial Code	Patients Accrued	Patients - Whole Blood	Patients - Cellular Component of Blood	Patients - DNA extracted from Blood	Patients - RNA extracted from Blood	Patients - Plasma	Patients - Serum	Patients - Urine	Patients - Buccal
GENITO-URINARY	PR21	224	192	0	0	0	192	0	0	0