A Phase II Trial of Potency-Sparing Hormonal Therapy in Patients With Elevated Serum PSA After Radiation Therapy or Radical Prostatectomy for Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- finasteride
- Conditions
- Prostate Cancer
- Sponsor
- Alliance for Clinical Trials in Oncology
- Enrollment
- 101
- Locations
- 43
- Primary Endpoint
- PSA levels
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
RATIONALE: Male hormones can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide and finasteride may fight prostate cancer by reducing the production of male hormones.
PURPOSE: Phase II trial to study the effectiveness of flutamide and finasteride in treating prostate cancer patients with high PSA levels who were previously treated with radiation therapy or radical prostatectomy.
Detailed Description
OBJECTIVES: * Determine the efficacy of finasteride and flutamide in suppressing prostate specific antigen (PSA) levels in patients with elevated PSA after definitive radiation therapy or radical prostatectomy for prostate cancer. * Assess sexual function and other quality of life issues during this therapy. * Estimate the response to flutamide withdrawal in this group of patients who have not had a major reduction in circulating testosterone levels. * Measure the response rate to further hormonal manipulation with combined androgen blockade after the failure of this therapy. * Obtain data that may predict more aggressive disease. OUTLINE: This is a multicenter study. Patients receive finasteride and flutamide by mouth three times a day. Patients experiencing recurrence or a greater than 4 nu/mL (above 50%) increase in PSA level will discontinue flutamide treatments. Otherwise, patients continue therapy in the absence of unacceptable toxicity or disease progression. Quality of life is assessed prior to therapy and at 3 and 6 months. Patients are followed every 3 months for one year and every 6 months thereafter. PROJECTED ACCRUAL: This study will accrue 100 patients over 2 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Hormone Therapy
Treatment of prostate cancer pts post radiation or surgery with potency sparing hormones
Intervention: finasteride
Hormone Therapy
Treatment of prostate cancer pts post radiation or surgery with potency sparing hormones
Intervention: flutamide
Hormone Therapy
Treatment of prostate cancer pts post radiation or surgery with potency sparing hormones
Intervention: quality-of-life assessment
Outcomes
Primary Outcomes
PSA levels
Time Frame: 1 year post treatment
Secondary Outcomes
- QOL issues associated with treatment protocol(3 & 6 months)