Spots Global Cancer Trial Database for Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
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Trial Identification
Brief Title: Hormone Therapy Plus Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Prostate Cancer
Official Title: A Phase III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) vs AS and RT Followed by Chemotherapy With Paclitaxel, Estramustine, and Etoposide (TEE) for Localized, High-Risk, Prostate Cancer
Study ID: NCT00004054
Conditions
Study Description
Brief Summary: RATIONALE: Hormones can stimulate the production of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. 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 plus radiation therapy is more effective with or without combination chemotherapy for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy plus radiation therapy with or without combination chemotherapy in treating patients who have prostate cancer.
Detailed Description: OBJECTIVES: * Compare the efficacy of androgen suppression and radiotherapy with or without subsequent paclitaxel, estramustine, and etoposide, in terms of overall and disease-free survival, biochemical and local control, and freedom from distant metastasis, in patients with localized high-risk prostate cancer. * Compare the toxic effects of these regimens in these patients. OUTLINE: This is a randomized study. Patients are stratified according to prostate-specific antigen level (≤ 10 ng/mL vs 11-100 ng/mL), tumor stage (T1-2 vs T3-4), Gleason score (7 vs 8-10), and prior hormone use (yes vs no). Patients are randomized to one of two treatment arms. All patients receive androgen suppression comprising a luteinizing hormone-releasing hormone (LHRH) agonist AND bicalutamide OR flutamide for 4 months. Beginning 8 weeks after the initiation of androgen suppression, all patients undergo radiotherapy once daily, 5 days a week, for 7-8 weeks. Patients who received prior androgen suppression therapy count time to radiotherapy from start date of prior hormonal therapy. * Arm I: Patients continue androgen suppression therapy (LHRH agonist only) for approximately 20 more months after radiotherapy is completed. * Arm II: Patients continue therapy as in arm I and receive chemotherapy beginning 28 days after completing radiotherapy. Chemotherapy comprises oral estramustine 3 times daily and oral etoposide twice daily on days 1-14 and paclitaxel IV over 1 hour on day 2. Chemotherapy repeats every 21 days for 4 courses. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,440 patients will be accrued for this study within 6 years.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
Foundation for Cancer Research and Education, Phoenix, Arizona, United States
Mount Diablo Medical Center, Concord, California, United States
Sutter Health Western Division Cancer Research Group, Greenbrae, California, United States
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Denver, Colorado, United States
Baptist Hospital of Miami, Miami, Florida, United States
Lutheran General Cancer Care Center, Park Ridge, Illinois, United States
Methodist Cancer Center at Methodist Hospital, Indianapolis, Indiana, United States
Ball Memorial Hospital Cancer Center, Muncie, Indiana, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Anne Arundel Oncology Center, Annapolis, Maryland, United States
Greater Baltimore Medical Center and Cancer Center, Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Marquette General Hospital, Marquette, Michigan, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Veterans Affairs Medical Center - East Orange, East Orange, New Jersey, United States
Monmouth Medical Center, Long Branch, New Jersey, United States
South Jersey Regional Cancer Center, Millville, New Jersey, United States
Atlantic City Medical Center, Pomona, New Jersey, United States
Fox Chase Cancer Center at St. Francis Medical Center, Trenton, New Jersey, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States
Akron General Medical Center, Akron, Ohio, United States
Akron City Hospital, Akron, Ohio, United States
CCOP - Columbus, Columbus, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
CCOP - Toledo Community Hospital, Toledo, Ohio, United States
John and Dorothy Morgan Cancer Center at Lehigh Valley Hospital, Allentown, Pennsylvania, United States
St. Luke's Hospital Cancer Center, Bethlehem, Pennsylvania, United States
Delaware County Memorial Hospital, Drexel Hill, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center, Philadelphia, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
Wellspan Health - York Cancer Center, York, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Dixie Regional Medical Center, Saint George, Utah, United States
LDS Hospital, Salt Lake City, Utah, United States
University Cancer Center at University of Washington Medical Center, Seattle, Washington, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin, United States
St. Vincent Hospital, Green Bay, Wisconsin, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
St. Luke's Medical Center, Milwaukee, Wisconsin, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
All Saints Cancer Center at All Saints Healthcare, Racine, Wisconsin, United States
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, Canada
Contact Details
Name: Howard M. Sandler, MD
Affiliation: University of Michigan Rogel Cancer Center
Role: STUDY_CHAIR
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