Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
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.