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Title: Hydrogel Spacer Prospective Multicenter Randomized Controlled Pivotal Trial: Dosimetric and Clinical Effects of Perirectal Spacer Application in Men Undergoing Prostate Image Guided Intensity Modulated Radiation Therapy

Purpose: Perirectal spacing, whereby biomaterials are placed between the prostate and rectum, shows promise in reducing rectal dose during prostate cancer radiation therapy. A prospective multicenter randomized controlled pivotal trial was performed to assess outcomes following absorbable spacer (SpaceOAR system) implantation. Methods and Materials: Overall, 222 patients with clinical stage T1 or T2 prostate cancer underwent computed tomography (CT) and magnetic resonance imaging (MRI) scans for treatment planning, followed with fiducial marker placement, and were randomized to receive spacer injection or no injection (control). Patients received postprocedure CT and MRI planning scans and underwent image guided intensity modulated radiation therapy (79.2 Gy in 1.8-Gy fractions). Spacer safety and impact on rectal irradiation, toxicity, and quality of life were assessed throughout 15 months. Results: Spacer application was rated as “easy” or “very easy” 98.7% of the time, with a 99% hydrogel placement success rate. Perirectal spaces were 12.6 ± 3.9 mm and 1.6 ± 2.0 mm in the spacer and control groups, respectively. There were no device-related adverse events, rectal perforations, serious bleeding, or infections within either group. Pre-to postspacer plans had a significant reduction in mean rectal V70 (12.4% to 3.3%, P<.0001). Overall acute rectal adverse event rates were similar between groups, with fewer spacer patients experiencing rectalmore » pain (P=.02). A significant reduction in late (3-15 months) rectal toxicity severity in the spacer group was observed (P=.04), with a 2.0% and 7.0% late rectal toxicity incidence in the spacer and control groups, respectively. There was no late rectal toxicity greater than grade 1 in the spacer group. At 15 months 11.6% and 21.4% of spacer and control patients, respectively, experienced 10-point declines in bowel quality of life. MRI scans at 12 months verified spacer absorption. Conclusions: Spacer application was well tolerated. Increased perirectal space reduced rectal irradiation, reduced rectal toxicity severity, and decreased rates of patients experiencing declines in bowel quality of life. The spacer appears to be an effective tool, potentially enabling advanced prostate RT protocols.« less
Authors:
 [1] ;  [2] ;  [3] ;  [4] ;  [5] ;  [6] ;  [7] ;  [8] ;  [9] ;  [10] ;  [11] ;  [12] ;  [13] ;  [14] ;  [15] ;  [16] ;  [17] ;  [18] ;  [19] ;  [20] more »; « less
  1. Associated Medical Professionals of New York, Syracuse, New York (United States)
  2. 21st Century Oncology, East Bradenton, Florida (United States)
  3. Western New York Urology Associates, Cancer Care of WNY, Cheektowaga, New York (United States)
  4. The Urology Center of Colorado, Denver, Colorado (United States)
  5. Chesapeake Urology Research Associates, The Prostate Center, Owings Mills, Maryland (United States)
  6. Arizona Oncology Services Foundation, Phoenix, Arizona (United States)
  7. Urological Surgeons of Northern California, Campbell, California (United States)
  8. The Research Foundation of State University of New York, SUNY Upstate Medical University, Syracuse, New York (United States)
  9. Peninsula Cancer Center, Poulsbo, Washington (United States)
  10. Urology Nevada, Reno, Nevada (United States)
  11. University Hospitals Case Medical Center, Cleveland, Ohio (United States)
  12. Sutter Health Sacramento Sierra Region, Sutter Institute for Medical Research, Sacramento, California (United States)
  13. Advanced Radiation Centers of New York, Lake Success, New York (United States)
  14. Oregon Urology Institute, Springfield, Oregon (United States)
  15. University of Rochester, Rochester, New York (United States)
  16. CentraState Medical Center, Freehold, New Jersey (United States)
  17. Carolina Regional Cancer Center, 21st Century Oncology, Myrtle Beach, South Carolina (United States)
  18. 21st Century Oncology, Fort Meyers, Florida (United States)
  19. Emory University, Atlanta, Georgia (United States)
  20. The Johns Hopkins University, Baltimore, Maryland (United States)
Publication Date:
OSTI Identifier:
22462391
Resource Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 92; Journal Issue: 5; Other Information: Copyright (c) 2015 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; BIOLOGICAL MATERIALS; COMPUTERIZED TOMOGRAPHY; FIDUCIAL MARKERS; INJECTION; IRRADIATION; NEOPLASMS; NMR IMAGING; PAIN; PATIENTS; PLANNING; PROSTATE; RADIATION DOSES; RADIOTHERAPY; RECTUM; SPACERS; STANDARD OF LIVING; TOXICITY