A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Subjects with Metastatic Prostate Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503254-12-00

Acronym

64091742PCR3001

Enrollment

235

Registered

2024-04-03

Start date

2019-03-06

Completion date

Unknown

Last updated

2025-12-09

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

Conditions

Metastatic Prostate Cancer

Brief summary

Radiographic progression-free survival (rPFS)

Interventions

DRUGABIRATERONE

DRUGDEGARELIX

DRUGNiraparib - capsule - 100 mg

DRUGRELUGOLIX

DRUGNiraparib tosylate monohydrate+ abiraterone acetate - Film coated tablet- 159.40 mg (eq. 100mg base)+ 500mg

DRUGPlacebo for Niraparib

DRUGPrednison acis 5 mg

DRUGTabletten

DRUGNiraparib tosylate monohydrate + abiraterone acetate - Film coated tablet- 79.90 mg (eq. 50mg base)+ 500mg

DRUGTECHNETIUM (99MTC) COMPOUNDS

DRUG-

DRUGAbiraterone acetate - tablet - 250 mg

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Radiographic progression-free survival (rPFS)	—

Countries

Belgium, Czechia, France, Germany, Hungary, Italy, Poland, Portugal, Spain, Sweden

Outcome results

None listed

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