A Randomized Gene Fusion Stratified Phase 2 Trial Of Abiraterone With Or Without ABT888 For Patients With Metastatic Castration-Resistant Prostate Cancer (NCI# 9012)
This study is researching all of the following topics:Prostate cancer
Location of study visits:
Ann Arbor, MI
This study is looking for:
Volunteers with specific conditions
The main purpose of this study is to look at the role of a specific gene hybrid formed from two previously separate genes to see if it can predict response to abiraterone with prednisone or abiraterone with prednisone plus experimental drug ABT-
888 in patients with prostate cancer.
Who can participate?
You may be eligible to participate in this study if you meet ALL of these main criteria :
Gender is Male
Age (years) is greater than or equal to 18
Currently has Prostate cancer
Patients with up to 2 prior chemotherapy regimens are eligible.
Patients must be able to take oral medication without crushing, dissolving or chewing tablets.
Patients may have received prior radiation therapy or surgery. However, at least 21 days must have elapsed since completion of radiation therapy or surgery and patient must have recovered from all side effects at the time of registration.
Patients with history of active seizures are not eligible.
Have testosterone < 50 ng/dL.
Patients must discontinue antiandrogen therapy for at least 4 weeks prior to registration with no evidence of a falling PSA after washout.
This study is seeking healthy individuals that meet ALL of the following:
What is involved?After agreeing to participate in the study and signing an informed consent document, participants will have screening tests to see if they meet the criteria to participate in the study. If criteria are met based on the testing and procedures, participants will be registered to the study. Within 10 days after study registration, participants will have a bone or tissue biopsy from an area of the body where the cancer has spread. The biopsy will be evaluated to determine gene fusion status (ETS gene fusion positive or negative). This will determine which group a participant will be in.
Participants will then be randomized to one of two treatment arms by chance (like flipping a coin). The groups are:
-Abiraterone and prednisone (standard of care) or
-Abiraterone and prednisone (standard of care) plus ABT-888 (experimental drug)
Particpants will receive the treatment within 2 working days after randomization.
Participants randomized to abiraterone and prednisone will take abiraterone by mouth once every day for 28 days of each 28 day cycle and prednisone by mouth twice every day for 28 days of each 28 day cycle. Every 28 days (4 weeks) is one cycle, example: first 28 days is cycle 1, next 28 days is cycle 2, etc.
Participants randomized to abiraterone and prednisone plus ABT-888 will take abiraterone by mouth once starting on day 8 of the first cycle of study treatment, then will take abiraterone every day for the rest of the 28 day cycle. For all other cycles after cycle 1 participants will take abiraterone every day for 28 days of each 28 day cycle, and will also take prednisone by mouth twice every day starting on day 8 of the first cycle of study treatment. Participants will then take prednisone every day for the rest of the 28 day cycle. For all other cycles after cycle 1 participants will take prednisone every day for 28 days of each 28 day cycle. Particpants will take ABT-888 twice daily during all cycles.