Study of I-131-1095 Radiation Therapy in Combination With Enzalutamide in Patients With Metastatic Castration-resistant Prostate Cancer Who Are Chemotherapy Naive and Have Progressed on Abiraterone

Official Title

A Multicentre, Randomized, Controlled Phase 2 Study: Efficacy and Safety of I-131-1095 Radiation Therapy in Combination With Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Who Are 18F-DCFPyL Prostate-specific Membrane Antigen (PSMA)-Avid, Chemotherapy-naive, and Progressed on Abiraterone

Summary:

This is a multicentre, randomized, controlled, phase 2 clinical trial designed to evaluate the safety and efficacy of I-131-1095 radiation therapy in combination with enzalutamide compared to enzalutamide alone in patients with prostate-specific membrane antigen (PSMA)-avid metastatic castration resistant prostate cancer (mCRPC) who have progressed on abiraterone. Patients must be chemotherapy-naive and must be ineligible or refuse to receive taxane-based chemotherapy at time of study entry. PSMA-avidity will be determined by central imaging review based on assessment of 18F-DCFPyL PET/CT imaging during screening. Eligible patients meeting the PSMA-avidity criteria will be randomized in a 2:1 ratio to receive either I-131-1095 in combination with enzalutamide (80 subjects) or enzalutamide alone (40 subjects). Patients will be followed for efficacy and safety assessments during a 12-month Randomized Treatment period. Patients will be followed for an additional year for safety and survival status. Safety data will be monitored by an independent Data Monitoring Committee and the sponsor.

Trial Description

Primary Outcome:

  • PSA response rate
Secondary Outcome:
  • Objective response rate (ORR)
  • Progression free survival (PFS)
  • Time to initiation of next treatment for prostate cancer
  • Overall survival (OS)
  • Safety and tolerability of I-131-1095 in combination with enzalutamide: CTCAE v5.0

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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