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Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations

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NCT05457257 · results posted

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Merck Sharp & Dohme LLC, Foundation Medicine, Myriad Genetics, Inc..

Phase
Phase 4
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
43actual
Sites
35
Country
China

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
DateFiledBasisWhat it is
Start2022-07-29actualWhen the study began enrolling
Primary completion2024-10-22actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-12-31estimatedThe whole study's end, after follow-up
First posted2022-07-13actualWhen this record first appeared on the registry
Results posted2025-12-19actualWhen the sponsor posted results to the registry
Record updated2026-04-21actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Metastatic Castration-resistant Prostate Cancer

Interventions

  • Drug: olaparib — also filed as Lynparza
  • Drug: enzalutamide — also filed as XTANDI
  • Drug: abiraterone acetate — also filed as ZYTIGA
  • Drug: Prednisone

Primary outcome

what the primary-completion date above is the date OF
Radiological Progression-free Survival - Based on Blinded Independent Central Review (BICR)
measured Tumor assessments every 8 weeks (± 1 week) relative to the date of randomization until radiological progression as assessed by BICR or death (median duration of treatment of 9 and 6 months for Olaparib and Investigators Choice of NHA respectively).

Posted documents

hosted by the registry — we link, never re-serve
Study Protocolposted 2023-04-13 · 2.6 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-09-23 · 9.3 MB · SAP_001.pdf

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