Talazoparib Plus Enzalutamide After Progression to Prior ARPi in Metastatic Prostate Cancer

Study acronym: TEAM PC
StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Jan 31, 2026 → Dec 31, 2027
See other at-risk trials from Fundacion Oncosur

Record History

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  1. Notable Primary completion pushed from Jan 31, 2026 to Dec 31, 2027 Show 6 more changesShow less
    • Trial sites expanded: 12 → 19 locations
    • Study completion pushed from Oct 31, 2027 to Feb 28, 2029
    • Eligibility criteria expanded, about 282 words
    • Secondary endpoints: details revised at 4 of 7 entries
    • Study description shortened, about 31 words
    • Study title shortened, about 1 word
  2. Minor Study sites: 1 to 12v2
  3. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this clinical trial is to determine the anti-tumor activity of talazoparib plus enzalutamide as first line treatment for metastatic castration resistant prostate cancer (mCRPC) in participants whose disease has progressed on Androgen Receptor Pathway Inhibitor (ARPI). The main questions it aims to answer are: * Does talazoparib plus enzalutamide improve efficacy in metastatic castration resistant prostate cancer (mCRPC) compared to enzalutamide alone? * What is the time to disease progression \[radiographic, Prostate Specific Antigen (PSA), clinical\] in participants treated with talazoparib plus enzalutamide after progression on abiraterone? * What medical problems do participants have when receiving talazoparib plus enzalutamide? Researchers will compare the combination of talazoparib and enzalutamide as a first-line treatment for mCRPC to see if the combination improves the PSA response rate and delays progression compared to enzalutamide alone. The safety and tolerability of the combination (talazoparib and enzalutamide) will also be studied
Trial Details
NCT Number NCT06582628
Lead Sponsor Fundacion Oncosur
Conditions
(from sponsor)
Metastatic Prostate Cancer
Related terms Prostatic Diseases, Prostatic Neoplasms
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov