Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
← catalyst calendarSponsored by Pfizer (industry) · PFE — their whole pipeline →. With Astellas Pharma Inc.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
1,054actual
Sites
369
Countries
Argentina, Australia, Belgium +23
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2017-12-18 | actual | When the study began enrolling |
| Primary completion | 2022-10-03 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-06-30 | estimated | The whole study's end, after follow-up |
| First posted | 2018-01-10 | actual | When this record first appeared on the registry |
| Results posted | 2024-01-17 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-08-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- mCRPC
Interventions
- Drug: Talazoparib with enzalutamide
- Drug: Placebo with enzalutamide
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1
measured Post dose on Day 1 up to Day 66 in Part 1
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1
measured Post dose on Day 1 up to Day 66 in Part 1
Number of Participants With All-Causality TEAEs During the Overall Period of Part 1
measured Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1
measured Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
measured Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1
measured Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
Blinded Independent Central Review (BICR) Assessed Radiographic Progression-Free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for All-Comers - Part 2 Cohort 1
measured From the start of treatment to the time of first documented progression, or death (maximum up to 42 months)
BICR Assessed rPFS Per RECIST 1.1 in Patients With DDR Deficiencies - Part 2
measured From the start of treatment to the time of first documented progression, or death (maximum up to 38 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2021-06-17 · 4.7 MB · Prot_000.pdf
Statistical Analysis Planposted 2022-07-01 · 4.5 MB · SAP_001.pdf
Publications
- PMID 42502892 — linked by the registry
- PMID 42261883 — linked by the registry
- PMID 42237765 — linked by the registry
- PMID 40683290 — linked by the registry
- PMID 40683287 — linked by the registry
- PMID 40179907 — linked by the registry
- PMID 40179906 — linked by the registry
- PMID 39737542 — linked by the registry
- PMID 39486165 — linked by the registry
- PMID 39451095 — linked by the registry
- PMID 38995237 — linked by the registry
- PMID 38452327 — linked by the registry
- PMID 38049622 — linked by the registry
- PMID 37285865 — linked by the registry
- PMID 35080190 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
Permalink · PFE's whole pipeline · Catalyst calendar · Every registered study · What changed