S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy

Phase 2

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Abiraterone acetate + prednisone	abiraterone acetate	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
Abiraterone acetate + prednisone	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

Primary Outcome Measures

Name	Time	Method
Number of Patients With Undetectable PSA	12 months	undetectable PSA defined as \<= 0.2 ng/mL. Patients not responding in the first year were deemed non-responders.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Toxicity of Abiraterone Acetate	Up to 3 years	Only adverse events that are possibly, probably or definitely related to study drug are reported.
Objective Progression-free Survival	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.
Number of Patients With PSA Partial Response	12 months	PSA reduction to \< 4 ng/ml, but \>0.2 ng/ml
Overall Survival	3 years

Locations (205): NEA Medical Clinic - East Matthews
🇺🇸
Jonesboro, Arkansas, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
Highlands Oncology Group - Springdale
🇺🇸
Rogers, Arkansas, United States
Kaiser Permanente - Deer Valley
🇺🇸
Antioch, California, United States
Kaiser Permanente - Fremont
🇺🇸
Fremont, California, United States
Kaiser Permanente Fresno Medical Center
🇺🇸
Fresno, California, United States
Kaiser Permanente Medical Center - Hayward
🇺🇸
Hayward, California, United States
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
🇺🇸
Marysville, California, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸
Oakland, California, United States
Kaiser Permanente Medical Center - Redwood City
🇺🇸
Redwood City, California, United States
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NEA Medical Clinic - East Matthews
🇺🇸Jonesboro, Arkansas, United States