A Randomised, Double-blind, Placebo-controlled, Multicentre Phase III Study of Olaparib Plus Abiraterone Relative to Placebo Plus Abiraterone as First-line Therapy in Men with Metastatic Castration-resistant Prostate Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511144-86-00

Acronym

PROpel D081SC00001

Enrollment

183

Registered

2024-03-14

Start date

2019-02-14

Completion date

Unknown

Last updated

2024-11-15

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

Conditions

Metastatic castration-resistant prostate cancer

Brief summary

Radiological progression free survival (rPFS) defined as the time from randomisation to radiological progression, or death from any cause, whichever occurs first

Detailed description

Overall survival (OS), Time to first subsequent anticancer therapy or death (TFST), Time to pain progression (TTPP), Time to first opiate use for cancer-related pain, Time to first symptomatic skeletal-related event (SSRE), Time to second progression or death (PFS2), BPI-SF: progression in pain severity domain, change in pain interference domain, FACT-P total score, FACT-G total score, trial outcome index, functional well-being, physical well being, prostate cancer subscale, and FACT Advanced Prostate Symptom Index 6 (FAPSI 6), HRR gene status, Plasma concentration data at steady state for olaparib, abiraterone, and Δ4-abiraterone in the subset of patients evaluable for PK

Interventions

DRUGLynparza 150 mg film-coated tablets

DRUGABIRATERONE

DRUGLynparza 100 mg film-coated tablets

DRUGPREDNISOLONE

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Radiological progression free survival (rPFS) defined as the time from randomisation to radiological progression, or death from any cause, whichever occurs first	—

Secondary

Measure	Time frame
Overall survival (OS), Time to first subsequent anticancer therapy or death (TFST), Time to pain progression (TTPP), Time to first opiate use for cancer-related pain, Time to first symptomatic skeletal-related event (SSRE), Time to second progression or death (PFS2), BPI-SF: progression in pain severity domain, change in pain interference domain, FACT-P total score, FACT-G total score, trial outcome index, functional well-being, physical well being, prostate cancer subscale, and FACT Advanced Prostate Symptom Index 6 (FAPSI 6), HRR gene status, Plasma concentration data at steady state for olaparib, abiraterone, and Δ4-abiraterone in the subset of patients evaluable for PK	—

Measure

Time frame

—

Countries

Belgium, Czechia, France, Italy, Netherlands, Slovakia

Outcome results

None listed

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