A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants with Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506365-64-00

Acronym

67652000PCR3002

Enrollment

211

Registered

2024-03-28

Start date

2020-10-16

Completion date

Unknown

Last updated

2026-01-13

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

Conditions

Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Brief summary

Radiographic progression-free survival (rPFS)

Interventions

DRUGNiraparib - capsule - 100 mg

DRUGPrednison acis 5 mg

DRUGTabletten

DRUGPlacebo for NIRAPARIB / ABIRATERONE ACETATE 100/500 mg FDC

DRUGPlacebo for Niraparib

DRUGRELUGOLIX

DRUG-

DRUGABIRATERONE

DRUGNiraparib

DRUGPlacebo for NIRAPARIB / ABIRATERONE ACETATE 50/500 mg FDC

DRUGTECHNETIUM (99MTC) COMPOUNDS

DRUGPlacebo for ABIRATERONE ACETATE

DRUGPREDNISOLONE

DRUGAbiraterone acetate - tablet - 250 mg

DRUGDEGARELIX

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

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

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

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

Countries

Belgium, Bulgaria, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain, Sweden

Outcome results

None listed

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