NCI/CTEP 9012: A Randomized Gene Fusion Stratified Phase 2 Trial of Abiraterone with or without ABT-888 for Patients with Metastatic Castration-Resistant Prostate Cancer

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NCI/CTEP 9012: A Randomized Gene Fusion Stratified Phase 2 Trial of Abiraterone with or without ABT-888 for Patients with Metastatic Castration-Resistant Prostate Cancer

Primary Objectives: (1) To evaluate the role of ETS gene fusion as a predictive biomarker for response to hormone therapy (abiraterone) alone or hormone therapy plus PARP-1 targeted therapy (ABT-888) in patients with metastatic castration resistant prostate cancer. (2) To evaluate whether the addition of PARP-1 targeted therapy is superior to hormone therapy alone based on ETS gene fusion status.
Secondary objectives: (1) Rate of PSA declines. (2) Objective response rate. (3) Progression-free survival. (4) Evaluate the qualitative and quantitative toxicity of abiraterone acetate with and without ABT-888.

Protocol Number081209
Principal InvestigatorMark Stein
PhasePhase II
ScopeNational
Applicable Disease SitesProstate
Therapies InvolvedChemotherapy multiple agents systemic
Chemotherapy single agent systemic
Drugs InvolvedAbiraterone
PREDNISONE
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.