Spots Global Cancer Trial Database for Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
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Trial Identification
Brief Title: Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
Official Title: Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate
Study ID: NCT00091390
Conditions
Study Description
Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer.
Detailed Description: OBJECTIVES: Primary * Determine the rate of late grade 3 or greater genitourinary and gastrointestinal toxicity after treatment with external beam radiotherapy and high-dose rate brachytherapy in patients with stage II or III adenocarcinoma of the prostate. Secondary * Determine acute grade 3 or greater genitourinary and gastrointestinal toxicity in patients treated with this regimen. * Determine freedom from biochemical failure in patients treated with this regimen. * Determine overall survival of patients treated with this regimen. * Determine disease-specific survival of patients treated with this regimen. * Determine clinical relapse (local and/or distant) in patients treated with this regimen. * Develop a quality assurance process for high-dose rate prostate brachytherapy. OUTLINE: This is a multicenter study. Patients are stratified according to prostate-specific antigen (≤ 10 ng/mL vs 11-20 ng/mL), T stage (T1c-T2c vs T3a-T3b), combined Gleason score (2-6 vs 7 vs 8-10), prior hormonal therapy (no vs yes), and timing of high-dose rate brachytherapy (before external beam radiotherapy vs after external beam radiotherapy). Patients are followed at 3, 7, 9, and 12 months, every 6 months for 5 years, and then annually thereafter.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Providence Saint Joseph Medical Center - Burbank, Burbank, California, United States
Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital, Inglewood, California, United States
Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center, Aurora, Colorado, United States
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center, Boca Raton, Florida, United States
OSF St. Francis Medical Center, Peoria, Illinois, United States
Maine Center for Cancer Medicine and Blood Disorders - Scarborough, Scarborough, Maine, United States
William Beaumont Hospital - Royal Oak Campus, Royal Oak, Michigan, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Fletcher Allen Health Care - University Health Center Campus, Burlington, Vermont, United States
Waukesha Memorial Hospital Regional Cancer Center, Waukesha, Wisconsin, United States
Contact Details
Name: I-Chow J. Hsu, MD
Affiliation: University of California, San Francisco
Role: STUDY_CHAIR
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