Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer
A Phase 1, Three-Part, Open-Label, Parallel-Cohort Safety and Tolerability Study of Relugolix in Combination With Abiraterone Acetate Plus a Corticosteroid, Apalutamide, or Docetaxel With or Without Prednisone in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer
Sponsor: Sumitomo Pharma America, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Incidence of Adverse Events
Time frame: Baseline through Week 13
Secondary Endpoints
Mean Testosterone Serum Concentrations at Baseline (Day 1), Week 5, and Week 13
Number and Proportion of Participants with Testosterone Concentrations ≥ 50 ng/dL at Baseline (Day 1), Week 5, and Week 13
Relugolix Trough Concentrations at Baseline (Day 1), Week 3, Week 5, Week 9, and Week 13
Eligibility Criteria
Key Inclusion Criteria: 1. A previous diagnosis of adenocarcinoma of the prostate confirmed by histologic or cytologic evidence and with a documented medical history of either: * mCSPC (Parts 1, 2, and 3) defined as having at least two of three risk factors at the baseline (Day 1) visit: * Total Gleason score of ≥ 6; and * Presence of ≥ 2 metastatic lesions on bone scan; OR * Radiologic evidence of measurable visceral metastases with exception of hepatic metastases. * nmCRPC (Part 2 only) defined as disease progression despite maintaining castration levels of testosterone with androgen deprivation therapy (ADT), as evidenced by an increase in consecutive prostate-specific antigen (PSA) concentrations (2 measurements, at least one week apart). * mCRPC (Parts 1 and 3) defined as disease progression despite maintaining castration levels of testosterone with ADT: * An increase in consecutive PSA (2 measurements at least 1 week apart); or * Worsening cl…
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