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.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the prostate recurrent prostate cancer Quality of Life sexual dysfunction and infertility	Procedure: supportive care  Procedure: hormone therapy  Procedure: endocrine therapy  Procedure: antiandrogen therapy  Behavior: supportive care/therapy  Behavior: psychosocial assessment/care  Drug: a-reductase inhibition  Procedure: quality-of-life assessment  Drug: finasteride  Drug: flutamide	Phase II

Further Study Details: 

OBJECTIVES: I. 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. II. Assess sexual function and other quality of life issues during this therapy. III. Estimate the response to flutamide withdrawal in this group of patients who have not had a major reduction in circulating testosterone levels. IV. Measure the response rate to further hormonal manipulation with combined androgen blockade after the failure of this therapy. V. Obtain data that may predict more aggressive disease.

PROTOCOL 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.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Histologically proven previously treated adenocarcinoma of the prostate

Prior definitive therapy must have occurred at least 6 months, but no more than 10 years, prior to study

• Definitive therapy is defined as: Prior radical prostatectomy OR Radiotherapy to the prostate no more than 3 months before prostatectomy OR Brachytherapy OR Brachytherapy with external beam radiotherapy given as single therapy OR External beam radiation therapy alone

Must have a PSA level between 1-10 nu/mL, with a rise of at least 1 nu/mL above the nadir produced by definitive therapy

No evidence of local recurrence

No metastatic disease

--Prior/Concurrent Therapy--

Biologic therapy: Not specified

Chemotherapy: No prior chemotherapy for prostate cancer

Endocrine therapy:

• At least 2 years since finasteride or other 5a-reductase inhibitors
• At least 12 months since prior hormone therapy for prostate cancer
• No more than 6 months of prior hormone therapy
• No corticosteroids in excess of standard replacement doses
• No concurrent systemic steroids
• No other concurrent antiandrogenic drugs or 5a-reductase inhibitors

Radiotherapy:

• See Disease Characteristics
• No concurrent palliative radiotherapy

Surgery:

• See Disease Characteristics
• No orchiectomy

--Patient Characteristics--

Age: Not specified

Performance status: ECOG 0-2

Life expectancy: Not specified

Hematopoietic: Not specified

Hepatic:

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• SGOT/SGPT no greater than 2 times ULN

Renal: Creatinine no greater than 2 times ULN

Other: Fertile patients must use effective contraception

Alabama
      Veterans Affairs Medical Center - Birmingham, Birmingham,  Alabama,  35233-1996,  United States
California
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94143-0128,  United States
      University of California San Diego Cancer Center, La Jolla,  California,  92093-0658,  United States
      Veterans Affairs Medical Center - San Francisco, San Francisco,  California,  94121,  United States
Delaware
      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States
District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States
Florida
      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States
Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States
      Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago,  Illinois,  60612,  United States
Iowa
      Holden Comprehensive Cancer Center at The University of Iowa, Iowa City,  Iowa,  52242-1009,  United States
Maine
      Veterans Affairs Medical Center - Togus, Togus,  Maine,  04330,  United States
Maryland
      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States
Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States
      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States
Minnesota
      Veterans Affairs Medical Center - Minneapolis, Minneapolis,  Minnesota,  55417,  United States
Missouri
      Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States
      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States
      Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia,  Missouri,  65201,  United States
      Washington University Siteman Cancer Center, Saint Louis,  Missouri,  63110,  United States
Nebraska
      University of Nebraska Medical Center, Omaha,  Nebraska,  68198-3330,  United States
Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States
New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756-0002,  United States
New York
      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States
      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse,  New York,  13217,  United States
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States
      Mount Sinai Medical Center, NY, New York,  New York,  10029,  United States
      New York Presbyterian Hospital - Cornell Campus, New York,  New York,  10021,  United States
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States
      Schneider Children's Hospital at North Shore, Manhasset,  New York,  11030,  United States
      State University of New York - Upstate Medical University, Syracuse,  New York,  13210,  United States
      Veterans Affairs Medical Center - Buffalo, Buffalo,  New York,  14215,  United States
      Veterans Affairs Medical Center - Syracuse, Syracuse,  New York,  13210,  United States
North Carolina
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States
      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States
      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States
      Veterans Affairs Medical Center - Durham, Durham,  North Carolina,  27705,  United States
Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States
Tennessee
      University of Tennessee, Memphis Cancer Center, Memphis,  Tennessee,  38103,  United States
      Veterans Affairs Medical Center - Memphis, Memphis,  Tennessee,  38104,  United States
Vermont
      Veterans Affairs Medical Center - White River Junction, White River Junction,  Vermont,  05009,  United States
Virginia
      MBCCOP - Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States
      Veterans Affairs Medical Center - Richmond, Richmond,  Virginia,  23249,  United States

Study chairs or principal investigators

Joel Picus,  Study Chair,  Cancer and Leukemia Group B   

Study ID Numbers:  CDR0000066274; CLB-9782
Record last reviewed:  August 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003323
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08