Olaparib and abiraterone in metastatic prostate cancer
Research type
Research Study
Full title
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
IRAS ID
250180
Contact name
Noel Clarke
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2018-002011-10
Duration of Study in the UK
3 years, 9 months, 27 days
Research summary
This research study is a double-blind, phase 3 trial evaluating the efficacy and safety (including evaluating side effects) of combination of olaparib and abiraterone versus placebo and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have received no prior cytotoxic chemotherapy or new hormonal agent at mCRPC stage.
Study participants will undergo screening, treatment and follow-up period. The screening period can last up to 28 days and may require several visits. Eligible participants are males at least 18 years old and who consent to participate in the study and meet the study mandatory entry criteria. Study participants will be divided into 2 groups and will receive study medications at random assigned by a computer program. Approximately 720 subjects will be randomized 1:1 (olaparib plus abiraterone: placebo plus abiraterone) into the trial. Patients will be trained on how to use an electronic device to report their pain and symptoms at various time during the study.
During the treatment period, patients will be required to attend the study clinic for study visits and assessments. The follow-up period occurs once the patient's cancer has been confirmed as progressing by radiologic imaging.
This study is expected to last up to 4 years.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
18/EM/0269
Date of REC Opinion
2 Nov 2018
REC opinion
Further Information Favourable Opinion