NCT00003323

Hormone Therapy in Treating Patients With Prostate Cancer

A Phase II Trial of Potency-Sparing Hormonal Therapy in Patients With Elevated Serum PSA After Radiation Therapy or Radical Prostatectomy for Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Sexual Dysfunction and Infertility

Interventions

Type	Name	Description
DRUG	finasteride	5 mg/d PO
DRUG	flutamide	250 mg PO tid
OTHER	quality-of-life assessment	Assessment survey administered at baseline, and 3 \& 6 months post initiation of treatment

Timeline

• Start date: 1998-05-01
• Primary completion: 2002-05-01
• Completion: 2010-03-01
• First posted: 2003-08-13
• Last updated: 2016-07-04

Locations

43 sites across 1 country: United States