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

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

Interventional

Enrollment (Actual)

101

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

  1. Histologic Documentation: Previous histologic evidence of adenocarcinoma of the prostate.
  2. 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.

    1. 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.
    2. 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.

    1. No therapy within 2 years with finasteride or other 5 alpha-reductase inhibitors.
    2. No previous chemotherapy for this malignancy.
    3. No orchiectomy.
    4. No corticosteroids in excess of standard replacement doses for adrenal failure.
  3. 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.

  4. No clear evidence of local recurrence on the digital rectal exam.
  5. No metastatic disease on the CT or bone scan.
  6. Performance status 0-2
  7. Required initial laboratory data

    1. SGOT and/or SGPT ≤2 x upper limits of normal
    2. Creatinine ≤2 x upper limits of normal
    3. Bilirubin ≤2 x upper limits of normal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Joel Picus, MD, Washington University Siteman Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1998

Primary Completion (Actual)

May 1, 2002

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

August 12, 2003

First Posted (Estimate)

August 13, 2003

Study Record Updates

Last Update Posted (Estimate)

July 4, 2016

Last Update Submitted That Met QC Criteria

July 1, 2016

Last Verified

July 1, 2016

More Information

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.

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