Investigational drug study for Metastatic Castration-resistant Prostate Cancer

Trial ID:
IRB-19-7343
Michael P. Kosty, M.D.
The purpose of this study is to evaluate the effectiveness, safety and tolerability of an investigational medication called Olaparib plus standard treatment compared to a placebo for the treatment of metastatic castration-resistant prostate cancer (mCRPC). All treatments and physician visits during this study will take place at Scripps Clinic Torrey Pines.

Abiraterone is already an approved medication for the treatment of some patients with prostate cancer. This medication is indicated in combination with prednisone or prednisolone for the treatment of mCRPC. The combination of olaparib and abiraterone as used in this study is experimental and is not approved by the FDA.

Patients have a 1 in 2 (50/50) chance of receiving either olaparib plus abiraterone or placebo plus abiraterone.

Inclusion Criteria

  • Be 18 years or older
  • Have progressive mCRPC

Exclusion Criteria

  • Have additional malignancy that has had progressed or required active treatment in last 5 years
  • Have a diagnosis of or suspected MDS/AML
  • Have clinically significant cardiovascular disease
  • Have had a prior revascularization procedure (significant coronary, carotid or peripheral artery stenosis)

Additional Info

  • Abiraterone is currently approved by the FDA for the treatment of mCRPC and is considered the standard treatment. Olaparib (Lynparza™) has been approved by the FDA for the treatment of recurrent ovarian cancer and for a certain type of breast cancer but is not approved to treat mCRPC and is considered experimental in this study. Eligible patients will be randomized to receive either olaparib plus standard treatment or standard treatment plus placebo.

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