A Phase II Trial of Potency-Sparing Hormonal Therapy in Patients With Elevated Serum PSA After Radiation Therapy or Radical Prostatectomy for Prostate Cancer
- 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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1 year post treatment
Joel Picus, MD
Washington University Siteman Cancer Center
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Walter Reed Army Medical Center||Washington, District of Columbia 20307-5000|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|University of Massachusetts Memorial Medical Center||Worcester, Massachusetts 01655|
|Lineberger Comprehensive Cancer Center, UNC||Chapel Hill, North Carolina 27599-7295|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Rhode Island Hospital||Providence, Rhode Island 02903|
|CCOP - Southern Nevada Cancer Research Foundation||Las Vegas, Nevada 89106|
|University of California San Diego Cancer Center||La Jolla, California 92093-0658|
|UCSF Cancer Center and Cancer Research Institute||San Francisco, California 94115-0128|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|CCOP - Mount Sinai Medical Center||Miami Beach, Florida 33140|
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland||Baltimore, Maryland 21201|
|Ellis Fischel Cancer Center - Columbia||Columbia, Missouri 65203|
|Barnes-Jewish Hospital||Saint Louis, Missouri 63110|
|Norris Cotton Cancer Center||Lebanon, New Hampshire 03756|
|CCOP - North Shore University Hospital||Manhasset, New York 11030|
|State University of New York - Upstate Medical University||Syracuse, New York 13210|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|University of Tennessee, Memphis Cancer Center||Memphis, Tennessee 38103|
|MBCCOP - Massey Cancer Center||Richmond, Virginia 23298-0037|
|Mount Sinai Medical Center, NY||New York, New York 10029|
|New York Presbyterian Hospital - Cornell Campus||New York, New York 10021|
|Holden Comprehensive Cancer Center at The University of Iowa||Iowa City, Iowa 52242-1009|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Veterans Affairs Medical Center - Birmingham||Birmingham, Alabama 35233|
|Veterans Affairs Medical Center - White River Junction||White River Junction, Vermont 05009|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Veterans Affairs Medical Center - Chicago (Westside Hospital)||Chicago, Illinois 60612|
|Veterans Affairs Medical Center - San Francisco||San Francisco, California 94121|
|CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.||Syracuse, New York 13217|
|Veterans Affairs Medical Center - Memphis||Memphis, Tennessee 38104|
|Veterans Affairs Medical Center - Richmond||Richmond, Virginia 23249|
|Veterans Affairs Medical Center - Togus||Togus, Maine 04330|
|Veterans Affairs Medical Center - Minneapolis||Minneapolis, Minnesota 55417|
|Veterans Affairs Medical Center - Columbia (Truman Memorial)||Columbia, Missouri 65201|
|University of Nebraska Medical Center||Omaha, Nebraska 68198-3330|
|Veterans Affairs Medical Center - Buffalo||Buffalo, New York 14215|
|Veterans Affairs Medical Center - Syracuse||Syracuse, New York 13210|
|Veterans Affairs Medical Center - Durham||Durham, North Carolina 27705|
|Schneider Children's Hospital at North Shore||Manhasset, New York 11030|
|Washington University Siteman Cancer Center||Saint Louis, Missouri 63110|