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NCT04821622Phase 3ACTIVE NOT RECRUITING

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

Study Summary

The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC.

Conditions
Prostate Cancer
Interventions / Drugs
talazoparib plus enzalutamidePlacebo plus enzalutamide
View on ClinicalTrials.gov ↗
Sponsor
PFE
Pfizer Inc
Diversified Pharma
F33/100
Study Details
Enrollment599 participants
Primary Completion—
Lead SponsorPfizer
Data Retrieved2026-04-11 02:55:53.189657+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 599 participants
Sponsor Catalyst Profile

Pfizer Inc (PFE) is the sponsoring company for this trial. BiotechSign currently grades this company F (33/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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