Evaluation of SpaceOARâ„¢ System When Used to Create Space Between the Rectum and Prostate in Men Undergoing IG-IMRT for Localized Stage T1-T2 Prostate Cancer: A Randomized, Multicenter, Parallel Arm Controlled Clinical Study
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Proportion of subjects achieving a reduction of 25% or greater in percent volume of the rectum receiving at least 70 Gy measured from CT scans acquired pre and post SpaceOAR hydrogel injection
3 months post index procedure
No
United States: Food and Drug Administration
AGX-11-001-US
NCT01538628
January 2012
May 2014
Name | Location |
---|---|
Foundation for Cancer Research and Education | Phoenix, Arizona 85013 |
University of Rochester | Rochester, New York 14642 |
Emory University | Atlanta, Georgia 30322 |
CentraState Medical Center | Freehold, New Jersey 07728 |
Radiological Associates of Sacramento | Sacramento, California 95816 |
Upstate Medical University | Syracuse, New York 13210 |
University Hospitals Case Medical Center | Cleveland, Ohio 44106 |
Oregon Urology Institute | Springfield, Oregon 97477 |
The Urology Center of Colorado | Denver, Colorado 80211 |
21st Century Oncology | Cape Coral, Florida 33990 |
Associated Medical Professionals of NY | Syracuse, New York 13210 |
Urological Surgeons of Northern California | Campbell, California 95008 |
Lakewood Ranch Oncology Center/21st Century Oncology | Bradenton, Florida 34202 |
Johns Hopkins University Department of Radiation Oncology and Molecular Radiation Sciences | Baltimore, Maryland 21231 |
Chesapeake Urology Associates, Chesapeake Urology Research Associates (The Prostate Center) | Owings Mills, Maryland 21117 |
Advanced Radiation Centers of New York | Lake Success, New York 11042 |
21st Century Oncology | Myrtle Beach, South Carolina 29577 |
Peninsula Cancer Center | Poulsbo, Washington 98370 |
Northern Nevada Radiation Oncology | Reno, Nevada 89521 |
Western New York Urology Associates, LLC and D/B/A Cancer Care of WNY | Erie, Niagara, and Chautauqua County, New York 14267 |