CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 1,054 enrolled
Drug / intervention
Talazoparib with enzalutamide +1 moredrug
Likely dose
Talazoparib 0.5 mg/day plus enzalutamide 160 mg/dayAI-extracted
Key inclusion· 7
  • ✓Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell or signet cell features
  • ✓Asymptomatic or mildly symptomatic metastatic CRPC (pain score on BPI-SF Question #3 < 4)
  • ✓Surgically or medically castrated with serum testosterone ≤50 ng/dL (≤1.73 nmol/L)
  • ✓Metastatic disease documented on bone scan or CT/MRI
Key exclusion· 8
  • ✕Any prior systemic cancer treatment in non-metastatic CRPC or mCRPC disease state
  • ✕Prior second-generation AR inhibitors (enzalutamide, apalutamide, darolutamide), PARP inhibitors, cyclophosphamide, or mitoxantrone
  • ✕Platinum-based chemotherapy within 6 months prior to enrollment OR any disease progression on platinum within 6 months
  • ✕Opioids for cancer-related pain within 28 days prior to enrollment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03395197
NCT03395197Phase 3Active
CompareCT.gov

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

Pfizer·interventional·Posted Jan 10, 2018·Updated Apr 22, 2026

In Brief

A Phase 3 clinical trial evaluating Talazoparib with enzalutamide and Placebo with enzalutamide for mCRPC. Active but no longer recruiting, targeting 1,054 participants across 368 sites in 26 countries.

Detailed Summary

This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsmCRPC
CountriesArgentina, Australia, Belgium, Brazil, Canada, Chile, China, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Japan, New Zealand, Norway, Peru, Poland, Portugal, South Africa, South Korea, Spain, Sweden, United Kingdom, United States
CollaboratorsAstellas Pharma Inc

Timeline

Phase 3Active
2018201920202021202220232024202520262027
First PostedJan 10, 2018
Enrollment StartDec 18, 2017
Primary CompletionOct 3, 2022
Study CompletionJun 30, 2027
TodayJul 1, 2026
Enrollment to primary: 4.8 yearsPosted 8.5 years ago

Interventions

Talazoparib with enzalutamidedrug

Talazoparib 0.5 mg/day plus enzalutamide 160mg/day

Placebo with enzalutamidedrug

Placebo plus enzalutamide 160 mg/day