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

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.