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.
OBJECTIVES: Primary * 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). Secondary * 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily
5 mg, oral, 5 mg twice daily
Number of Patients With Undetectable PSA
undetectable PSA defined as \<= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders.
Time frame: 12 months
Number of Patients With PSA Partial Response
PSA reduction to \< 4 ng/ml, but \>0.2 ng/ml
Time frame: 12 months
Objective Progression-free Survival
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.
Time frame: 3 years
Overall Survival
Time frame: 3 years
Number of Patients With Toxicity of Abiraterone Acetate
Only adverse events that are possibly, probably or definitely related to study drug are reported.
Time frame: Up to 3 years
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