S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antiandrogen drugs, such as abiraterone acetate, may lessen the amount of androgens made by the body. It may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well abiraterone acetate works in treating patients with prostate cancer who have undergone initial hormone therapy.
Drug: abiraterone acetate
Drug: leuprolide acetate
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II|
- Rates of undetectable PSA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Overall survival and objective progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Toxicity of abiraterone acetate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Abiraterone acetate + prednisone
Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily
Prednisone, 5 mg, oral, 5 mg twice daily
|Drug: abiraterone acetate Drug: degarelix Drug: leuprolide acetate Procedure: orchiectomy|
- To assess the rate of achieving a prostate-specific antigen (PSA) of ≤ 0.2 ng/mL with abiraterone acetate therapy in men with metastatic prostate cancer with a sub-optimal response to androgen-deprivation therapy (ADT).
- To assess the overall survival and objective progression-free survival of this group of patients.
- To assess PSA partial response.
- To evaluate the qualitative and quantitative toxicity of abiraterone acetate.
OUTLINE: This is a multicenter study.
Patients receive abiraterone acetate orally daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive androgen blockade with GNRH agonist (goserelin acetate or leuprolide acetate) or a GNRH antagonist (degarelix) per the treating physician and this will be given continuously until evidence of disease progression. Bilateral surgical orchiectomy is also acceptable.
After completion of study therapy, patients are followed up every 3 months for 1 year and then every 6 months for up to 3 years.