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)
Condition: Metastatic Castration-resistant Prostate Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT02987543
Phase: Phase 3
- Age: minimum 18 Years maximum 130 Years
- Gender: Male
- Histologically confirmed diagnosis of prostate cancer.
- Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
- 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 .
- Ongoing therapy with LHRH analog or bilateral orchiectomy.
- Radiographic progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
- Qualifying HRR mutation in tumor tissue.
- Any previous treatment with PARP inhibitor, including olaparib.
- 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.
- 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.
- Subjects with known brain metastases.
View trial on ClinicalTrials.gov