Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer

June 13, 2023 updated by: Eastern Cooperative Oncology Group

A Phase III Randomized Trial for Evaluating Second Line Hormonal Therapy (Ketoconazole/Hydrocortisone) Versus Paclitaxel/Estramustine Combination Chemotherapy on Progression Free Survival in Asymptomatic Patients With a Rising PSA After Hormonal Therapy for Prostate Cancer

RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as ketoconazole may stop the production of androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective than combination chemotherapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with that of combination chemotherapy in treating patients who have prostate cancer that has been previously treated with androgen suppression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare time to objective progression in patients with prostate cancer and a rising prostate-specific antigen (PSA) after androgen suppression when treated with second-line hormonal therapy (ketoconazole and hydrocortisone) vs combination chemotherapy (docetaxel and estramustine).
  • Compare time to PSA progression and correlate this with time to objective progression in patients treated with these regimens.
  • Compare the quality of life in patients treated with these regimens.
  • Compare overall survival of patients treated with these regimens.
  • Compare the natural history of progression in patients treated with these regimens.
  • Identify prognostic indicators of clinical outcome by immunohistochemical evaluation of apoptopic biomarkers in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior treatment with bisphosphonates (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral ketoconazole three times daily and oral hydrocortisone twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive oral estramustine three times daily on days 1-5 and docetaxel IV over 1 hour on day 2. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, on day 1 of week 9, at 6 months and 1 year, and then annually for up to 10 years or until beginning of first non-protocol therapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 590 patients (295 per treatment arm) will be accrued for this study within 4 years.

Study Type

Interventional

Phase

  • Phase 3

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

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Comprehensive Cancer Institute
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5404
        • CCOP - Mayo Clinic Scottsdale Oncology Program
      • Tucson, Arizona, United States, 85723
        • Veterans Affairs Medical Center - Tucson
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Veterans Affairs Medical Center - Little Rock
    • California
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • La Jolla, California, United States, 92093-0658
        • Rebecca and John Moores UCSD Cancer Center
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
      • Martinez, California, United States, 94553
        • Veterans Affairs Outpatient Clinic - Martinez
      • San Diego, California, United States, 92134-3202
        • Naval Medical Center - San Diego
      • San Francisco, California, United States, 94115
        • UCSF Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80012-0000
        • Medical Center of Aurora - South Campus
      • Boulder, Colorado, United States, 80301-9019
        • Boulder Community Hospital
      • Colorado Springs, Colorado, United States, 80933
        • Penrose Cancer Center at Penrose Hospital
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80220
        • Veterans Affairs Medical Center - Denver
      • Denver, Colorado, United States, 80218
        • Presbyterian - St. Luke's Medical Center
      • Denver, Colorado, United States, 80224
        • CCOP - Colorado Cancer Research Program, Incorporated
      • Denver, Colorado, United States, 80218-1191
        • St. Joseph Hospital
      • Denver, Colorado, United States, 80220
        • Rocky Mountain Cancer Centers - Denver Rose
      • Englewood, Colorado, United States, 80112
        • Swedish Medical Center
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, United States, 80501
        • Hope Cancer Care Center at Longmont United Hospital
      • Pueblo, Colorado, United States, 81004
        • St. Mary-Corwin Regional Medical Center
      • Thornton, Colorado, United States, 80221
        • Rocky Mountain Cancer Centers - Thornton
    • District of Columbia
      • Washington, District of Columbia, United States, 20307-5001
        • Walter Reed Army Medical Center
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Cancer Center at Memorial Regional Hospital
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
      • Tampa, Florida, United States, 33612
        • Veterans Affairs Medical Center - Tampa (Haley)
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Veterans Affairs Medical Center - Atlanta (Decatur)
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital Cancer Care Institute
      • Hines, Illinois, United States, 60141
        • Veterans Affairs Medical Center - Hines
      • Peoria, Illinois, United States, 61615-7828
        • CCOP - Illinois Oncology Research Association
      • River Forest, Illinois, United States, 60305
        • West Suburban Center for Cancer Care
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Cancer Center
      • Indianapolis, Indiana, United States, 46202
        • Veterans Affairs Medical Center - Indianapolis (Roudebush)
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
    • Kansas
      • Wichita, Kansas, United States, 67218
        • Veterans Affairs Medical Center - Wichita
    • Kentucky
      • Lexington, Kentucky, United States, 40502-2236
        • Veterans Affairs Medical Center - Lexington
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Veterans Affairs Medical Center - New Orleans
      • New Orleans, Louisiana, United States, 70121
        • CCOP - Ochsner
      • New Orleans, Louisiana, United States, 70112
        • MBCCOP - LSU Health Sciences Center
      • Shreveport, Louisiana, United States, 71101-4295
        • Veterans Affairs Medical Center - Shreveport
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Baltimore, Maryland, United States, 21201
        • Greenebaum Cancer Center at University of Maryland Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201-1932
        • Veterans Affairs Medical Center - Detroit
      • Kalamazoo, Michigan, United States, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, United States, 49007-3731
        • CCOP - Kalamazoo
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Veterans Affairs Medical Center - Jackson
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Cancer Center
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • CCOP - Southern Nevada Cancer Research Foundation
    • New Hampshire
      • Hooksett, New Hampshire, United States, 03106
        • New Hampshire Oncology-Hematology, PA - Hooksett
      • Lebanon, New Hampshire, United States, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108-5138
        • Veterans Affairs Medical Center - Albuquerque
      • Albuquerque, New Mexico, United States, 87131
        • MBCCOP - University of New Mexico HSC
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10016
        • NYU School of Medicine's Kaplan Comprehensive Cancer Center
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • Syracuse, New York, United States, 13210
        • Veterans Affairs Medical Center - Syracuse
    • North Carolina
      • Fayetteville, North Carolina, United States, 28302-2000
        • Cape Fear Valley Health System
      • Goldsboro, North Carolina, United States, 27534-9479
        • CCOP - Southeast Cancer Control Consortium
    • Ohio
      • Cincinnati, Ohio, United States, 45220-2288
        • Veterans Affairs Medical Center - Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
      • Columbus, Ohio, United States, 43206
        • CCOP - Columbus
      • Dayton, Ohio, United States, 45428-1002
        • Veterans Affairs Medical Center - Dayton
      • Toledo, Ohio, United States, 43623-3456
        • CCOP - Toledo Community Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97207
        • Veterans Affairs Medical Center - Portland
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
      • Philadelphia, Pennsylvania, United States, 19111-2497
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center at the University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29401-5799
        • Veterans Affairs Medical Center - Charleston
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • CCOP - Sioux Community Cancer Consortium
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6307
        • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
    • Texas
      • Amarillo, Texas, United States, 79106
        • Harrington Cancer Center
      • Amarillo, Texas, United States, 79106
        • Veterans Affairs Medical Center - Amarillo
      • San Antonio, Texas, United States, 78229
        • Veterans Affairs Medical Center - San Antonio (Murphy)
      • Temple, Texas, United States, 76504
        • Veterans Affairs Medical Center - Temple
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • Veterans Affairs Medical Center - Salt Lake City
    • Virginia
      • Charlottesville, Virginia, United States, 22902
        • Martha Jefferson Hospital
      • Roanoke, Virginia, United States, 24014
        • Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
    • Washington
      • Seattle, Washington, United States, 98108
        • Veterans Affairs Medical Center - Seattle
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • St. Mary's Medical Center
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54307-3453
        • CCOP - St. Vincent Hospital Cancer Center, Green Bay
      • Madison, Wisconsin, United States, 53792-0001
        • University of Wisconsin Comprehensive Cancer Center
      • Milwaukee, Wisconsin, United States, 53226-3596
        • Medical College of Wisconsin Cancer Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate that was continuously treated with androgen suppression
  • Rising prostate-specific antigen (PSA), defined as PSA > 5 ng/mL, rising on 2 consecutive measurements at least 4 weeks apart
  • Gleason score 7 or higher and/or seminal vesicle involvement at diagnosis

  • Patients previously treated with antiandrogen or glucocorticoid therapy must meet the following criteria:

    • Must show a continued rise in PSA after stopping antiandrogen (flutamide, bicalutamide, or nilutamide) or glucocorticoid (dexamethasone or prednisone)

      • At least 4 weeks continued rise in PSA after flutamide or nilutamide (6 weeks for bicalutamide)

  • Testosterone less than 50 ng/dL

    • Patients who have not undergone surgical castration must continue primary androgen suppression to maintain castrate levels of testosterone
  • No progressive or measurable local or metastatic disease (including bone metastases)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • SGOT no greater than 2 times upper limit of normal
  • Bilirubin no greater than 1.5 mg/dL

Renal:

  • Creatinine no greater than 1.7 mg/dL

Cardiovascular:

  • No American Heart Association class III or IV heart disease
  • No uncontrolled congestive heart failure
  • No life-threatening cardiac arrhythmias

Other:

  • Fertile patients must use effective contraception
  • No other prior malignancy unless curatively treated and disease-free for appropriate time period for specific cancer
  • No preexisting peripheral neuropathy greater than grade 1
  • No known hypersensitivity to polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 5 years since prior systemic chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • At least 4 weeks since prior hydrocortisone
  • No prior ketoconazole

Radiotherapy:

  • At least 28 days since prior radiotherapy to primary site
  • No prior palliative radiotherapy
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • Recovered form prior therapy
  • At least 7 days since prior parenteral antibiotics for active infection
  • No concurrent digitalis
  • No concurrent H_2 blockers or proton pump inhibitors (arm I only)
  • Concurrent bisphosphonates allowed provided they were initiated prior to study therapy

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: Randomized

Collaborators and Investigators

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

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)
Cancer and Leukemia Group B
SWOG Cancer Research Network

Investigators

  • Study Chair: Michael A. Carducci, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Study Chair: Nirmala Bhoopalam, MD, Veterans Affairs Medical Center - Hines
  • Study Chair: Gregory P. Swanson, MD, Deaconess Medical Center, Spokane, Washington
  • Study Chair: William Dahut, MD, National Cancer Institute (NCI)

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

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 (Actual)

October 8, 2003

Primary Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

December 7, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimated)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069088
  • E1899
  • SWOG-E1899
  • CALGB-E1899

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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