NCT01309672

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

Abiraterone Acetate Treatment for Prostate Cancer Patients With a PSA of More Than Four Following Initial Androgen Deprivation Therapy Phase II

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	abiraterone acetate	1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily
DRUG	Prednisone	5 mg, oral, 5 mg twice daily

Timeline

• Start date: 2011-08-09
• Primary completion: 2016-11-29
• Completion: 2024-04-11
• First posted: 2011-03-07
• Last updated: 2025-02-26
• Results posted: 2017-05-05

Locations

205 sites across 1 country: United States

Regulatory

• FDA-regulated drug study