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This study compares the drug Olaparib (Lynparza™) with Enzalutamide or Abiraterone acetate in men with metastatic castration-resistant prostate cancer who carry a qualifying mutation in a homologous recombination repair (HRR) gene. It enrolled patients whose disease had progressed after prior treatment with a new hormonal agent. The study was carried out in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion criteria 1. Histologically confirmed diagnosis of prostate cancer. 2. Documented evidence of metastatic castration resistant prostate cancer (mCRPC). 3. Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC . 4. Ongoing therapy with LHRH analog or bilateral orchiectomy. 5. Radiographic progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy). 6. Qualifying HRR mutation in tumor tissue. Exclusion criteria 1. Any previous treatment with PARP inhibitor, including olaparib. 2. Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose \> 5 years prior to randomization. 3. Other malignancy (including MDS and MGUS) within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥5 years. 4. Subjects with known brain metastases.