Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
q 3 mon for 2 yrs post tx initiation
Mark Hurwitz, MD
Dana-Farber/Brigham and Women's Cancer Center
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|CCOP - Kansas City||Kansas City, Missouri 64131|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|UMASS Memorial Cancer Center - University Campus||Worcester, Massachusetts 01605-2982|
|Ellis Fischel Cancer Center at University of Missouri - Columbia||Columbia, Missouri 65203|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University||Columbus, Ohio 43210-1240|
|CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.||Syracuse, New York 13217|
|Veterans Affairs Medical Center - Syracuse||Syracuse, New York 13210|
|Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute||Boston, Massachusetts 02115|
|Florida Hospital Cancer Institute at Florida Hospital Orlando||Orlando, Florida 32803-1273|
|SUNY Upstate Medical University Hospital||Syracuse, New York 13210|
|Presbyterian Cancer Center at Presbyterian Hospital||Charlotte, North Carolina 28233-3549|
|Wayne Memorial Hospital, Incorporated||Goldsboro, North Carolina 27534|
|Zimmer Cancer Center at New Hanover Regional Medical Center||Wilmington, North Carolina 28402-9025|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|
|Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees||Camden, New Jersey 08103|
|Beebe Medical Center||Lewes, Delaware 19958|
|St. Francis Hospital||Wilmington, Delaware 19805|
|Union Hospital Cancer Center at Union Hospital||Elkton MD, Maryland 21921|
|Community General Hospital of Greater Syracuse||Syracuse, New York 13215|
|Danville Regional Medical Center||Danville, Virginia 24541|
|Hudner Oncology Center at Saint Anne's Hospital||Fall River, Massachusetts 02721|
|Missouri Baptist Cancer Center||St. Louis, Missouri 63131|
|Washoe Cancer Services at Washoe Medical Center - Reno||Reno, Nevada 89502|
|Arch Medical Services, Incoroporated at Center for Cancer Care Research||Saint Louis, Missouri 63141|