Clinical trial NCT01088529
Conditions: Prostate Cancer
Keywords: Neoadjuvant Prostate Cancer Abiraterone Acetate LHRHa high risk prostate cancer Radical prostatectomy Prednisone Luteinizing Hormone-Releasing Hormone LHRH analogue
Sponsor: Cougar Biotechnology, Inc.
Start date: 2009-12-01; Completion date: 2013-03-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief 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.

Detailed description:
Study Groups:

Participants who are eligible to take part in this study will be randomly assigned (as in the flip of a coin) to 1 of 2 groups:

* Those who are in Group A will take abiraterone acetate, a LHRH analogue, and prednisone.
* Those who are in Group B will receive a LHRH analogue alone. Participants will have 2 out of 3 chances of being placed in Group A or 1 out of 3 chances of being placed in Group B.

Participants in both groups will receive the study drug(s) for about 3 months followed by a prostatectomy (prostate surgery) between 2 and 4 weeks after they stop taking the study drug(s).

Length of Study:

Participants will receive study drugs on this study for about 3 months before having surgery to remove their prostate about 2-4 weeks later. Participants will be removed from this study if the disease gets worse, if they experience intolerable side effects, or their study doctors feel that it is in their best interest to stop the study.

Long-Term Follow-Up:

Participants will return to the clinic 1 month, 3 months, 6 months, and then every 6 months (for up to 8 years) after your surgery for follow-up visits. Up to 66 patients will be take part in this study. All will be enrolled at M. D. Anderson after their surgery.

Arms: arm 1: Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy. arm 2: Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
Interventions: intervention 1: Abiraterone Acetate intervention 2: Prednisone intervention 3: LHRHa
Intervention descriptions: intervention 1: 1000 mg oral daily for 3 months followed by a prostatectomy. intervention 2: 5 mg orally daily. intervention 3: LHRH analogue (either leuprolide or goserelin): Leuprolide is an intramuscular injection, and goserelin subcutaneous (under skin) of abdomen, given either 1 injection every 3 months or 1 injection each month for 3 months.

Protocol documents: