Spots Global Cancer Trial Database for Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
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Trial Identification
Brief Title: Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
Official Title: Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer
Study ID: NCT00006359
Conditions
Study Description
Brief Summary: RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these drugs together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer.
Detailed Description: OBJECTIVES: * Determine the feasibility of androgen-suppression therapy combined with external-beam radiotherapy and boost brachytherapy (EBRT+BT) in patients with intermediate-risk localized prostate cancer. * Determine the safety of EBRT+BT in these patients. * Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local recurrence at 5 years, time to prostate-specific antigen failure, and time to first rectal/bladder injury, in these patients. OUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three times daily or oral bicalutamide once daily for 4 weeks. Within 4 weeks after initiation of androgen-suppression therapy, patients undergo external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds. Patients are followed every 3 months for 2 years and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Beebe Medical Center, Lewes, Delaware, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
St. Francis Hospital, Wilmington, Delaware, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando, Orlando, Florida, United States
Union Hospital Cancer Center at Union Hospital, Elkton MD, Maryland, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
Hudner Oncology Center at Saint Anne's Hospital, Fall River, Massachusetts, United States
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia, Missouri, United States
CCOP - Kansas City, Kansas City, Missouri, United States
Arch Medical Services, Incoroporated at Center for Cancer Care Research, Saint Louis, Missouri, United States
Missouri Baptist Cancer Center, St. Louis, Missouri, United States
Washoe Cancer Services at Washoe Medical Center - Reno, Reno, Nevada, United States
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees, Camden, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse, Syracuse, New York, United States
Community General Hospital of Greater Syracuse, Syracuse, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital, Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Zimmer Cancer Center at New Hanover Regional Medical Center, Wilmington, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, United States
Danville Regional Medical Center, Danville, Virginia, United States
Contact Details
Name: Mark Hurwitz, MD
Affiliation: Dana-Farber/Brigham and Women's Cancer Center
Role: STUDY_CHAIR
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