Phase II Trial Of Combined High Dose Rate Brachytherapy And External Beam Radiotherapy For Adenocarcinoma Of The Prostate
- 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.
- 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
- 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 undergo external beam radiotherapy over approximately 15 minutes once daily 5 days
a week for 5 weeks. Patients also receive two fractions (within a 24-hour period) of
high-dose rate brachytherapy (delivered through an implant inserted into the prostate) over
approximately 5-30 minutes either before or after external beam radiotherapy. Treatment
continues in the absence of disease progression or unacceptable toxicity.
Patients are followed at 3, 7, 9, and 12 months, every 6 months for 5 years, and then
PROJECTED ACCRUAL: A total of 110 patients will be accrued for this study within 1 year.
Masking: Open Label, Primary Purpose: Treatment
Late severe genitourinary (GU) and gastrointestinal (GI) toxicity as measured by CTCAE v3.0 more than 9 months after starting treatment
I-Chow J. Hsu, MD
University of California, San Francisco
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Providence Saint Joseph Medical Center - Burbank||Burbank, California 91505|
|Newark Beth Israel Medical Center||Newark, New Jersey 07112|
|University of Colorado Cancer Center at University of Colorado Health Sciences Center||Denver, Colorado 80010|
|Fletcher Allen Health Care - University Health Center Campus||Burlington, Vermont 05401|
|Maine Center for Cancer Medicine and Blood Disorders - Scarborough||Scarborough, Maine 04074|
|Waukesha Memorial Hospital Regional Cancer Center||Waukesha, Wisconsin 53188|
|William Beaumont Hospital - Royal Oak Campus||Royal Oak, Michigan 48073|
|OSF St. Francis Medical Center||Peoria, Illinois 61637|
|Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital||Inglewood, California 90301|
|Radiological Associates of Sacramento Medical Group, Incorporated||Sacramento, California 95815|
|Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center||Boca Raton, Florida 33486|