Clinical Trial TitleA randomized phase II trial of abiraterone, olaparib, or abiraterone + olaparib in patients with metastatic castration-resistant prostate cancer with DNA repair defects.
Clinical Trial Protocol Description:
The purpose of this study is to test the safety and tolerability of abiraterone, olaparib, or abiraterone + olaparib in patients with metastatic castration-resistant prostate cancer with DNA repair defects and to collect data.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are male and 18 years of age or older.
- Have histological or cytological proof of prostate adenocarcinoma. (Note: Small-cell carcinoma of the prostate is not permitted.)
- Have documented progressive mCRPC based on at least one of the following criteria:
- PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2.0 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2.0 ng/mL.
- Progression of bidimensionally measurable soft tissue or nodal metastasis assessed within one month prior to registration by a CT scan or MRI.
- Progression of bone disease (evaluable disease) (new bone lesion(s)) by bone scan.
- Agree to undergo a biopsy of at least one metastatic site to determine DNA repair defects.
You will be excluded from the study if any of the following criteria apply to you:
- Have prior exposure to CYP-17 (other than ketoconazole) or PARP inhibitors for prostate cancer. Patients with prior exposure to ketoconazole are eligible.
- Have prior chemotherapy for castration resistant disease. Chemotherapy given in the hormonesensitive setting is permissible if stopped at least 4 weeks prior to registration.
- Have prior exposure to enzalutamide, ARN-509 or other investigational AR-directed therapy in the setting of mCRPC.
- Have a currently active second malignancy excluding non-melanomatous skin cancer or superficial transitional cell carcinoma.
This is a partial list of inclusion and exclusion criteria.