Dataset from A Randomized, Open-Label, Neoadjuvant Prostate Cancer Trial of Abiraterone Acetate Plus LHRHa Versus LHRHa Alone
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The goal of this clinical research study is to find out how treatment with abiraterone acetate in combination with prednisone and a Luteinizing Hormone-Releasing Hormone (LHRH) analogue changes the tumor in comparison to treatment with an LHRH analogue alone. Objectives: Primary Objective: To assess the difference in pathologic stage < pT2 between Group A and Group B. Secondary Objective: - To assess and compare the changes in levels of androgens (pre, during, and post treatment) in the serum, primary tumor microenvironment and bone marrow between Group A and Group B. - To assess changes in biomarkers related to androgen signaling and other cancer-related pathways between Group A and Group B. - To assess the difference in rate of positive surgical margins between Group A and Group B. - To assess the safety profile of abiraterone acetate and low dose prednisone in a preoperative setting.



