Efficacy & safety of Olaparib in Castration-Resistant Prostate Cancer
Research type
Research Study
Full title
A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men with Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment with a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound)
IRAS ID
228836
Contact name
Johann DeBono
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2016-000300-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 5 months, 28 days
Research summary
This research study is an open-label, phase 3 trial evaluating the efficacy and safety of olaparib versus enzalutamide or abiraterone in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have a tumor mutation in one of 15 genes involved in the DNA repair [homologous recombination repair (HRR)] pathway of damaged DNA.
This study is intended to see if olaparib is effective in treating a certain type of prostate cancer with a defect in the way it repairs damage to DNA [mutation(s) in HRR genes], how it compares to enzalutamide or abiraterone, and which side effects it causes.
Study participants will be divided into two groups based on HRR gene mutation status. Approximately 340 subjects will be randomized 2:1 (olaparib: investigator choice of enzalutamide or abiraterone) into the trial.
Eligible participants are males 18 years and older who meet study entry criteria. Participants will undergo a screening, treatment and follow-up period. During screening, a patient's tumor will be tested to determine if it has a qualifying HRR mutation. For 7 days before the treatment period, a patient will be asked to fill out electronic questionnaires daily asking about their symptoms and medications. During the treatment period, in which participants will receive olaparib or enzalutamide or abiraterone, participants will be required to attend the study clinic for study visits and assessments and continue to complete questionnaires. The follow-up period occurs once the patient's cancer has been confirmed as progressing by radiologic imaging. If a patient's tumor is confirmed to have progressed by radiologic imaging while receiving one of the comparison drug treatments (enzalutamide or abiraterone), the patient will be given the option to receive olaparib.
This study is expected to last up to 3 years.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
17/LO/1511
Date of REC Opinion
10 Oct 2017
REC opinion
Further Information Favourable Opinion