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Home > "H" Clinical Trials Conditions > Hormone Therapy in Treating Patients With Prostate Cancer  Hormone Therapy in Treating Patients With Prostate Cancer
Hormone Therapy in Treating Patients With Prostate Cancer
For Condition: Quality of Life,sexual dysfunction and infertility,recurrent prostate cancer,adenocarcinoma of the prostate
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: /
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JoelPicus, Study Chair, Cancer and Leukemia Group B
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Washington University Siteman Cancer Center
St. Louis, Missouri, 63110
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233-1996
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Schneider Children's Hospital at North Shore
Manhasset, New York, 11030
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
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
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000066274; CLB-9782
Study Start Date: May 1998
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003323
Other Recurrent Prostate Cancer Studies:
1. Antineoplaston Therapy in Treating Patients With Metastatic Prostate Cancer
2. Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer
3. Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
4. Celecoxib in Treating Patients With Relapsed Prostate Cancer Following Radiation Therapy or Radical Prostatectomy
5. BMS-275291 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Related Studies:
Other recurrent prostate cancer Clinical Trials
Other Vermont Clinical Trials
Other White River Junction Clinical Trials
Hormone Therapy in Treating Patients With Prostate Cancer
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