Spots Global Cancer Trial Database for Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer
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Trial Identification
Brief Title: Hormone Therapy Compared With Combination Chemotherapy in Treating Patients With Prostate Cancer
Official Title: 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
Study ID: NCT00027859
Conditions
Study Description
Brief Summary: 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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Comprehensive Cancer Institute, Huntsville, Alabama, United States
CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale, Arizona, United States
Veterans Affairs Medical Center - Tucson, Tucson, Arizona, United States
Veterans Affairs Medical Center - Little Rock, Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center, Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, United States
Naval Medical Center - San Diego, San Diego, California, United States
UCSF Comprehensive Cancer Center, San Francisco, California, United States
Medical Center of Aurora - South Campus, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
St. Joseph Hospital, Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center, Denver, Colorado, United States
Rocky Mountain Cancer Centers - Denver Rose, Denver, Colorado, United States
Veterans Affairs Medical Center - Denver, Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, United States
St. Mary-Corwin Regional Medical Center, Pueblo, Colorado, United States
Rocky Mountain Cancer Centers - Thornton, Thornton, Colorado, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
Memorial Regional Cancer Center at Memorial Regional Hospital, Hollywood, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, United States
Veterans Affairs Medical Center - Tampa (Haley), Tampa, Florida, United States
Veterans Affairs Medical Center - Atlanta (Decatur), Decatur, Georgia, United States
MBCCOP - Hawaii, Honolulu, Hawaii, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines, Hines, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
West Suburban Center for Cancer Care, River Forest, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush), Indianapolis, Indiana, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States
Veterans Affairs Medical Center - Wichita, Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans, New Orleans, Louisiana, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, United States
Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Veterans Affairs Medical Center - Detroit, Detroit, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph, Michigan, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Missouri Baptist Cancer Center, Saint Louis, Missouri, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States
Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Mount Sinai Medical Center, New York, New York, United States
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, United States
Cape Fear Valley Health System, Fayetteville, North Carolina, United States
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, United States
Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton, Dayton, Ohio, United States
CCOP - Toledo Community Hospital, Toledo, Ohio, United States
Oklahoma University Medical Center, Oklahoma City, Oklahoma, United States
Veterans Affairs Medical Center - Portland, Portland, Oregon, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, United States
Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States
Veterans Affairs Medical Center - Charleston, Charleston, South Carolina, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, United States
Harrington Cancer Center, Amarillo, Texas, United States
Veterans Affairs Medical Center - Amarillo, Amarillo, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple, Temple, Texas, United States
CCOP - Scott and White Hospital, Temple, Texas, United States
Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, United States
Martha Jefferson Hospital, Charlottesville, Virginia, United States
Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke, Roanoke, Virginia, United States
Veterans Affairs Medical Center - Seattle, Seattle, Washington, United States
St. Mary's Medical Center, Huntington, West Virginia, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Contact Details
Name: Michael A. Carducci, MD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: STUDY_CHAIR
Name: Nirmala Bhoopalam, MD
Affiliation: Veterans Affairs Medical Center - Hines
Role: STUDY_CHAIR
Name: Gregory P. Swanson, MD
Affiliation: Deaconess Medical Center, Spokane, Washington
Role: STUDY_CHAIR
Name: William Dahut, MD
Affiliation: National Cancer Institute (NCI)
Role: STUDY_CHAIR
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