A Phase 2 Open-Label, Randomized, Multi-center Study of Neoadjuvant Abiraterone Acetate (CB7630) Plus Leuprolide Acetate and Prednisone Versus Leuprolide Acetate Alone in Men With Localized High Risk Prostate Cancer
This is an open-label (all people know the identity of the intervention), randomized (the
study drug is assigned by chance), and multi-center (conducted in more than one center)
study of abiraterone in male participants with prostate cancer. The duration of study will
be approximately 24-32 weeks per participant. The study consists of 4 parts: Screening (that
is, 30 days before study commences on Day 1); Treatment (abiraterone acetate 1000 milligram
per day or leuprolide acetate as 22.5 milligram intramuscular injection [injection of a
substance into a muscle] or prednisone 5 mg once daily); Prostatectomy (Week 24); and
Follow-up ( 4-8 weeks after prostatectomy). Participants will receive either abiraterone,
leuprolide and prednisone for 24 weeks (that is, Group 1) or leuprolide once every 12 weeks
up to Week 24 then abiraterone and prednisone from Week 13 to 24 (that is, Group 2). All the
eligible participants will be randomly assigned to 1 of the 2 treatment groups. Efficacy
will be evaluated primarily through the concentrations of testosterone and
dihydrotestosterone from prostate tissues at Week 12. Participants' safety will be monitored
throughout the study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Testosterone Concentration in Prostate Tissue
Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12.
Week 12
No
Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC
United States: Food and Drug Administration
CR016936
NCT00924469
November 2009
March 2012
Name | Location |
---|---|
Austin, Texas 78705 | |
Seattle, Washington 98195 | |
Boston, Massachusetts |