C3441052 - TALAPRO-3: A Phase 3, Randomized, Double-Blind Study of Talazoparib with Enzalutamide Versus Placebo with Enzalutamide in Men with DDR Gene Mutated Metastatic Castration-Sensitive Prostate Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510809-28-00

Acronym

C3441052

Enrollment

207

Registered

2024-06-10

Start date

2021-09-27

Completion date

Unknown

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Castration-sensitive Prostate Cancer

Brief summary

Investigator-assessed rPFS per Response Evaluation Criteria in Solid Tumors (RECIST 1.1 [soft tissue disease]) and Prostate Cancer Working Group (PCWG3 [bone disease]) in participants with mCSPC harboring HRR deficiencies.

Detailed description

OS in participants with mCSPC harboring HRR deficiencies (alpha protected).

Interventions

DRUGXtandi - 40 mg soft capsules

DRUGTALAZOPARIB

DRUGTalazoparib placebo

DRUGXtandi 40 mg soft capsules

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Investigator-assessed rPFS per Response Evaluation Criteria in Solid Tumors (RECIST 1.1 [soft tissue disease]) and Prostate Cancer Working Group (PCWG3 [bone disease]) in participants with mCSPC harboring HRR deficiencies.	—

Secondary

Measure	Time frame
OS in participants with mCSPC harboring HRR deficiencies (alpha protected).	—

Countries

Belgium, Bulgaria, Czechia, Finland, France, Germany, Hungary, Italy, Netherlands, Norway, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026