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Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

NCT03395197 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1054

Last updated 2026-04-22

Study results available
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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.

Conditions

Interventions

DRUG

Talazoparib with enzalutamide

Talazoparib 0.5 mg/day plus enzalutamide 160mg/day

DRUG

Placebo with enzalutamide

Placebo plus enzalutamide 160 mg/day

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-18
Primary Completion
2022-10-03
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • 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

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03395197 on ClinicalTrials.gov