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A Randomized Gene Fusion Stratified Phase 2 Trial Of Abiraterone With Or Without ABT888 For Patients With Metastatic Castration-Resistant Prostate Cancer (NCI# 9012)
Prostate Cancer ( Malignant tumor of prostate )
Location of study visits: Ann Arbor, MI
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.
This study is looking for: male   Only men
  • Volunteers with specific conditions
  • More than 18 years old
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.
11 HEROES have already shown interest in this study. I am interested Print Study | Email Study
Who can participate?
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.
Compensation This study does not offer any compensation.
More about the study

IRB number: HUM00060473
Activation Date: 04/01/2012    Deactivation Date: 03/30/2018
Study Team Principal Investigator:  Hussain, Maha
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