A Randomized, Open-Label, Neoadjuvant Prostate Cancer Trial of Abiraterone Acetate Plus LHRHa Versus LHRHa Alone
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
- 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
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
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.
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of Patients with Pathologic Stage ≤ pT2
Every 2-4 weeks prior to prostatectomy, 1 and 3 months after and every 6 months thereafter for 8 years.
Cougar Biotechnology, Inc. Clinical Trial
Cougar Biotechnology, Inc.
United States: Food and Drug Administration
|Austin, Texas 78705|
|UT MD Anderson Cancer Center||Houston, Texas 77030|