Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00002889
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Imaging procedures such as MRI may improve the ability to determine the response of prostate tumors to therapy.
PURPOSE: Phase II trial to study MRI results in patients with prostate cancer that has been treated with radiation therapy plus androgen suppression therapy.
- Detailed Description
OBJECTIVES: I. Establish whether changes between baseline and 2-month post androgen suppression endorectal coil MRI results predict for biochemical control following radiotherapy with androgen suppression in patients with adenocarcinoma of the prostate.
OUTLINE: Patients undergo a baseline endorectal coil MRI, followed by total androgen suppression (TAS) with either leuprolide IM or subcutaneous goserelin once a month plus oral flutamide 3 times a day for 2 months. Patients then receive a second endorectal coil MRI, followed by 2 months of external-beam radiotherapy plus TAS. Patients may receive an additional 2 months of TAS at the discretion of the treating physician. Patients are followed every 6 months for 3 years, then yearly thereafter.
PROJECTED ACCRUAL: Approximately 180 patients (approximately 60 per year) will be accrued for this study over a 34 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Efficacy 2 years post tx
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Joint Center for Radiation Therapy
🇺🇸Boston, Massachusetts, United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
St. Joseph's Hospital and Medical Center
🇺🇸Paterson, New Jersey, United States
Arthur G. James Cancer Hospital - Ohio State University
🇺🇸Columbus, Ohio, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States