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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (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|
- Number of Patients With Undetectable PSA [ Time Frame: 12 months ]undetectable PSA defined as <= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders.
- Number of Patients With PSA Partial Response [ Time Frame: 12 months ]PSA reduction to < 4 ng/ml, but >0.2 ng/ml
- Objective Progression-free Survival [ Time Frame: 3 years ]Progression defined as unequivocal progression of disease, progressive disease as defined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), progressive disease as defined by the Prostate Cancer Clinical Trials Working Group bone scan progression criteria, or death due to disease.
- Overall Survival [ Time Frame: 3 years ]
- Number of Patients With Toxicity of Abiraterone Acetate [ Time Frame: Up to 3 years ]Only adverse events that are possibly, probably or definitely related to study drug are reported.
|Study Start Date:||August 9, 2011|
|Estimated Study Completion Date:||October 2018|
|Primary Completion Date:||November 29, 2016 (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
1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken dailyDrug: Prednisone
5 mg, oral, 5 mg twice daily
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309672
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|Principal Investigator:||Thomas W. Flaig, MD||University of Colorado, Denver|