Hormone Therapy in Treating Patients With Prostate Cancer
- Conditions
- Prostate CancerSexual Dysfunction and Infertility
- Interventions
- Registration Number
- NCT00003323
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 101
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hormone Therapy quality-of-life assessment Treatment of prostate cancer pts post radiation or surgery with potency sparing hormones Hormone Therapy finasteride Treatment of prostate cancer pts post radiation or surgery with potency sparing hormones Hormone Therapy flutamide Treatment of prostate cancer pts post radiation or surgery with potency sparing hormones
- Primary Outcome Measures
Name Time Method PSA levels 1 year post treatment
- Secondary Outcome Measures
Name Time Method QOL issues associated with treatment protocol 3 & 6 months
Trial Locations
- Locations (43)
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Schneider Children's Hospital at North Shore
🇺🇸Manhasset, New York, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Veterans Affairs Medical Center - Togus
🇺🇸Togus, Maine, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Holden Comprehensive Cancer Center at The University of Iowa
🇺🇸Iowa City, Iowa, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
University of Tennessee, Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Washington University Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Memphis
🇺🇸Memphis, Tennessee, United States
Veterans Affairs Medical Center - Richmond
🇺🇸Richmond, Virginia, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States