Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

Key Facts

Primary Endpoints (CT.gov)

Secondary Endpoints

Eligibility Criteria

Inclusion Criteria: 1. Male participants at least 18 years of age at screening (20 years for Japan, 19 years for Republic of Korea). 2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, small cell or signet cell features. If the participant does not have a prior histological diagnosis, a baseline de novo biopsy must be used to confirm the diagnosis and may also be used to support biomarker analysis. 3. Confirmation of DDR gene mutation status by prospective or historical analysis (with sponsor pre-approval) of blood (liquid biopsy) and/or de novo or archival tumor tissue using FoundationOne Liquid CDx or FoundationOne CDx. 4. Willing to provide tumor tissue when available (de novo or archived) for retrospective molecular profiling analysis, if not already provided as part of inclusion criterion 3. 5. Unless prohibited by local regulations or ethics committee decision, consent to a saliva sample collection for retrospective…

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

Source

Related Program

Talazoparib (Talzenna) — TALAPRO-3

Pfizer