- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003323
Hormone Therapy in Treating Patients With Prostate Cancer
A Phase II Trial of Potency-Sparing Hormonal Therapy in Patients With Elevated Serum PSA After Radiation Therapy or Radical Prostatectomy for Prostate Cancer
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.
Study Overview
Status
Intervention / 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233-1996
- Veterans Affairs Medical Center - Birmingham
-
-
California
-
La Jolla, California, United States, 92093-0658
- University of California San Diego Cancer Center
-
San Francisco, California, United States, 94121
- Veterans Affairs Medical Center - San Francisco
-
San Francisco, California, United States, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
-
-
Delaware
-
Wilmington, Delaware, United States, 19899
- CCOP - Christiana Care Health Services
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20307-5000
- Walter Reed Army Medical Center
-
-
Florida
-
Miami Beach, Florida, United States, 33140
- CCOP - Mount Sinai Medical Center
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
-
Chicago, Illinois, United States, 60637-1470
- University of Chicago Cancer Research Center
-
-
Iowa
-
Iowa City, Iowa, United States, 52242-1009
- Holden Comprehensive Cancer Center at the University of Iowa
-
-
Maine
-
Togus, Maine, United States, 04330
- Veterans Affairs Medical Center - Togus
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
Worcester, Massachusetts, United States, 01655
- University of Massachusetts Memorial Medical Center
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55417
- Veterans Affairs Medical Center - Minneapolis
-
-
Missouri
-
Columbia, Missouri, United States, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
-
Columbia, Missouri, United States, 65203
- Ellis Fischel Cancer Center - Columbia
-
Saint Louis, Missouri, United States, 63110
- Barnes-Jewish Hospital
-
Saint Louis, Missouri, United States, 63110
- Washington University Siteman Cancer Center
-
-
Nebraska
-
Omaha, Nebraska, United States, 68198-3330
- University of Nebraska Medical Center
-
-
Nevada
-
Las Vegas, Nevada, United States, 89106
- CCOP - Southern Nevada Cancer Research Foundation
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center
-
-
New York
-
Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
-
Buffalo, New York, United States, 14215
- Veterans Affairs Medical Center - Buffalo
-
Manhasset, New York, United States, 11030
- CCOP - North Shore University Hospital
-
Manhasset, New York, United States, 11030
- Schneider Children's Hospital at North Shore
-
New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, United States, 10021
- New York Presbyterian Hospital - Cornell Campus
-
New York, New York, United States, 10029
- Mount Sinai Medical Center, NY
-
Syracuse, New York, United States, 13210
- State University of New York - Upstate Medical University
-
Syracuse, New York, United States, 13210
- Veterans Affairs Medical Center - Syracuse
-
Syracuse, New York, United States, 13217
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
-
Durham, North Carolina, United States, 27705
- Veterans Affairs Medical Center - Durham
-
Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
-
Winston-Salem, North Carolina, United States, 27104-4241
- CCOP - Southeast Cancer Control Consortium
-
Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
-
-
Tennessee
-
Memphis, Tennessee, United States, 38103
- University of Tennessee, Memphis Cancer Center
-
Memphis, Tennessee, United States, 38104
- Veterans Affairs Medical Center - Memphis
-
-
Vermont
-
White River Junction, Vermont, United States, 05009
- Veterans Affairs Medical Center - White River Junction
-
-
Virginia
-
Richmond, Virginia, United States, 23298-0037
- MBCCOP - Massey Cancer Center
-
Richmond, Virginia, United States, 23249
- Veterans Affairs Medical Center - Richmond
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- Histologic Documentation: Previous histologic evidence of adenocarcinoma of the prostate.
Prior Treatment:
2.1 Definitive Local Therapy: Patients must have had a previous attempt at definitive therapy, which is defined as a previous radical prostatectomy or radiation therapy with at least 5500 cGy to the prostate.
- Patients may have had both radiation therapy to the prostate and surgical resection, given as definitive therapy, provided they began the radiation therapy within 3 months of their prostatectomy. Also, brachytherapy alone and combinations of brachytherapy and external beam radiation therapy are also allowed, if given as a single therapy, and not given for a rising PSA after the previous therapy.
- The previous treatment must have occurred at least 6 months, but no more than 10 years, prior to registration.
2.2 Previous Hormonal Therapy or Other Treatments: Patients may have had no more than 6 months of hormonal therapy with their other treatment, and must have been off all hormones used for the treatment of prostate cancer including Megace for at least 12 months.
- No therapy within 2 years with finasteride or other 5 alpha-reductase inhibitors.
- No previous chemotherapy for this malignancy.
- No orchiectomy.
- No corticosteroids in excess of standard replacement doses for adrenal failure.
Elevated PSA Criteria:
3.1 Patients must a PSA level between 1 ng/ml and 10 ng/ml, with a rise of at least 1 ng/ml above the nadir produced by definitive therapy. The PSA level must be repeated at least once, one month later to confirm the rise of 1 ng/ml above nadir.
3.2 After the second PSA has been drawn to confirm the rise, one additional PSA should be drawn as close to the start of therapy as possible. Therefore, a total of three PSAs must be drawn prior to the start of therapy. Only the last two need to be drawn at the same lab (ie, the second confirmatory PSA and the PSA drawn just prior to the start of the trial). The nadir PSA and the initial PSA suggesting a rise can be drawn at outside laboratories. The combination of the nadir PSA and the two PSAs showing a rise of 1.0 ng/ml are used for determining eligibility. The two elevated PSAs must be at least one month apart.
- No clear evidence of local recurrence on the digital rectal exam.
- No metastatic disease on the CT or bone scan.
- Performance status 0-2
Required initial laboratory data
- SGOT and/or SGPT ≤2 x upper limits of normal
- Creatinine ≤2 x upper limits of normal
- Bilirubin ≤2 x upper limits of normal
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hormone Therapy
Treatment of prostate cancer pts post radiation or surgery with potency sparing hormones
|
5 mg/d PO
250 mg PO tid
Assessment survey administered at baseline, and 3 & 6 months post initiation of treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PSA levels
Time Frame: 1 year post treatment
|
1 year post treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
QOL issues associated with treatment protocol
Time Frame: 3 & 6 months
|
3 & 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Joel Picus, MD, Washington University Siteman Cancer Center
Publications and helpful links
General 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 record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Infertility
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Urological Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Androgen Antagonists
- 5-alpha Reductase Inhibitors
- Flutamide
- Finasteride
Other Study ID Numbers
- CALGB-9782
- U10CA031946 (U.S. NIH Grant/Contract)
- CDR0000066274 (Registry Identifier: NCI Physician Data Query)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on finasteride
-
Polichem S.A.CompletedAlopecia, AndrogeneticBelgium, Germany, Hungary, Russian Federation, Spain
-
GlaxoSmithKlineCompletedAndrogenetic AlopeciaJapan, Argentina, Peru, Philippines, Taiwan, Mexico, Chile, Russian Federation, Thailand
-
Elorac, Inc.Completed
-
EMSRecruitingAndrogenetic AlopeciaBrazil
-
Hospices Civils de LyonUnknown
-
Iran University of Medical SciencesFiruzgar hospital affiliated to Iran University of Medical SciencesCompletedIdiopathic Hirsutism
-
Polichem S.A.Completed
-
CancerCare ManitobaTerminatedNon-small Cell Lung CancerCanada
-
Follicle Pharma LtdRecruitingAndrogenic AlopeciaIsrael
-
Inventage Lab., Inc.CompletedAndrogenetic AlopeciaAustralia