Hormone Therapy in Treating Patients With Prostate Cancer

Condition(s) targeted: Prostate Cancer; Quality of Life; Sexual Dysfunction and Infertility

Intervention: finasteride (Drug); flutamide (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Cancer and Leukemia Group B

Official(s) and/or principal investigator(s):
Joel Picus, MD, Study Chair, Affiliation: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

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.

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

Study design: Treatment

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Male.

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 one of the following:

- Prior radical prostatectomy

- Radiotherapy to the prostate no more than 3 months before prostatectomy

- Brachytherapy

- Brachytherapy with external beam radiotherapy given as single therapy

- 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

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

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

Veterans Affairs Medical Center - Birmingham, Birmingham, Alabama 35233-1996, United States

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

CCOP - Christiana Care Health Services, Wilmington, Delaware 19899, United States

Walter Reed Army Medical Center, Washington, District of Columbia 20307-5000, United States

CCOP - Mount Sinai Medical Center, Miami Beach, Florida 33140, United States

University of Chicago Cancer Research Center, Chicago, Illinois 60637-1470, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago, Illinois 60612, United States

Holden Comprehensive Cancer Center at The University of Iowa, Iowa City, Iowa 52242-1009, United States

Veterans Affairs Medical Center - Togus, Togus, Maine 04330, United States

Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland 21201, United States

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

University of Massachusetts Memorial Medical Center, Worcester, Massachusetts 01655, United States

Veterans Affairs Medical Center - Minneapolis, Minneapolis, Minnesota 55417, United States

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

University of Nebraska Medical Center, Omaha, Nebraska 68198-3330, United States

CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada 89106, United States

Norris Cotton Cancer Center, Lebanon, New Hampshire 03756-0002, United States

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

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 Hospital, Providence, Rhode Island 02903, United States

University of Tennessee, Memphis Cancer Center, Memphis, Tennessee 38103, United States

Veterans Affairs Medical Center - Memphis, Memphis, Tennessee 38104, United States

Veterans Affairs Medical Center - White River Junction, White River Junction, Vermont 05009, United States

MBCCOP - Massey Cancer Center, Richmond, Virginia 23298-0037, United States

Veterans Affairs Medical Center - Richmond, Richmond, Virginia 23249, United States

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: May 1998
Last updated: May 23, 2008