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Hormone Therapy in Treating Patients With Prostate Cancer
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: August 19, 2009   History of Changes
Sponsor: Cancer and Leukemia Group B
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003323
  Purpose

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 Intervention Phase
Prostate Cancer
Sexual Dysfunction and Infertility
Drug: finasteride
Drug: flutamide
Procedure: quality-of-life assessment
Phase II

Study Type: Interventional
Study Design: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 100
Study Start Date: May 1998
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003323

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

Additional Information:
Publications:
Picus J, Halabi S, Small E, et al.: Long term efficacy of peripheral androgen blockade on prostate cancer: CALGB 9782. [Abstract] J Clin Oncol 24 (Suppl 18): A-4573, 2006.
Picus J, Halabi S, Small E, et al.: Efficacy of peripheral androgen blockade on prostate cancer: results of CALGB 9782. [Abstract] J Clin Oncol 22 (Suppl 14): A-4559, 396s, 2004.
Picus J, Halabi S, Hussain A, et al.: Efficacy of peripheral androgen blockade on prostate cancer: initial results of CALGB 9782. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-727, 2002.

Study ID Numbers: CDR0000066274, CLB-9782
Study First Received: November 1, 1999
Last Updated: August 19, 2009
ClinicalTrials.gov Identifier: NCT00003323     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer
sexual dysfunction and infertility

Additional relevant MeSH terms:
Infertility
Molecular Mechanisms of Pharmacological Action
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Urogenital Neoplasms
Genital Diseases, Male
Flutamide
Pharmacologic Actions
Genital Diseases, Female
Finasteride
Androgen Antagonists
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2009