Clinical Trial: NCT03395197
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Pfizer |
| Information Provided By: | Pfizer |
| Last Update Posted: | 2026-10-14 |
Study Overview
Brief 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.
Official Title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Conditions
mCRPC
Intervention / Treatment
- Drug: Talazoparib with enzalutamide
- Drug: Placebo with enzalutamide
Other Study ID Numbers
- C3441021
- 2017-003295-31
- TALAPRO-2
- 2023-509087-20-00
- 2023
- 2017
Start Date (Actual)
2017-12-18
Primary Completion Date (Actual)
2022-10-03
Study Completion Date (Estimated)
2027-06-30
Enrollment (Actual)
1054
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Pfizer |
| Information Provided By: | Pfizer |
| Last Update Posted: | 2026-10-14 |
Study Overview
Brief 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.
Official Title
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Conditions
mCRPC
Intervention / Treatment
- Drug: Talazoparib with enzalutamide
- Drug: Placebo with enzalutamide
Other Study ID Numbers
- C3441021
- 2017-003295-31
- TALAPRO-2
- 2023-509087-20-00
- 2023
- 2017
Start Date (Actual)
2017-12-18
Primary Completion Date (Actual)
2022-10-03
Study Completion Date (Estimated)
2027-06-30
Enrollment (Actual)
1054
Study Type
Interventional
Phase
Phase 3