This phase 3 trial will evaluate the safety and effectiveness of olaparib (Lynparza) and abiraterone (Zytiga) combination in prostate cancer.
The main outcome will be the rate of survival without cancer growing or spreading.
Prostate cancer (PC) is cancer that originates in the prostate gland. When cancer progresses to a different area of the body, it is called metastatic. One treatment for PC is surgery. Removal of the testes (castration) can be performed to treat PC. Not all patients respond to this option. Patients with metastatic castration-resistant PC (mCRPC) do not respond to many treatments. Olaparib (OPB)is a drug that blocks an enzyme called PARP. OPB has been used to treat certain breast cancers. It may be useful in combination with abiraterone (ABT) for the treatment of mCRPC. ABT blocks the production of testosterone.
This trial will evaluate the safety and effectiveness of olaparib and abiraterone combination in prostate cancer. The main outcome will be the rate of survival without cancer getting worse.
Who are they looking for?
This study will recruit 720 patients with mCRPC. Patients must have a life expectancy of at least 6 months and must have normal organ and bone marrow function. Patients must agree to use contraception during the study and for 3 months after the last dose of treatment.
Patients cannot take part in the trial if they have cancer originating in another area. Patients with leukemias, cardiovascular disease or uncontrolled hypertension are excluded from the study. Other exclusion criteria include a history of cardiac interventions, chronic uncontrolled medical conditions, brain tumors, active infections, or immuno-compromised patients.
How will it work
Patients will be randomly assigned to combination treatment (OPB and ABT) or monotherapy (placebo and ABT). Patients in the combination group will receive OPB (300mg, orally) twice daily. They will also take ABT (1000 mg, orally) once daily and prednisolone/prednisone (PRD/PRDL, 5 mg) twice daily. Patients in the monotherapy group will receive ABT, PRD/PRDL, and placebo. The study will last up to 4 years.
The main outcomes measured will be survival and side effects.