Neil Mariados1, John Sylvester2, Dhiren Shah3, Lawrence Karsh4, Richard Hudes5, David Beyer6, Steven Kurtzman7, Jeffrey Bogart8, R Alex Hsi9, Michael Kos10, Rodney Ellis11, Mark Logsdon12, Shawn Zimberg13, Kevin Forsythe14, Hong Zhang15, Edward Soffen16, Patrick Francke17, Constantine Mantz18, Peter Rossi19, Theodore DeWeese20, Daniel A Hamstra21, Walter Bosch22, Hiram Gay22, Jeff Michalski22. 1. Associated Medical Professionals of New York, Syracuse, New York. Electronic address: nmariados@ampofny.com. 2. 21st Century Oncology, East Bradenton, Florida. 3. Western New York Urology Associates, Cancer Care of WNY, Cheektowaga, New York. 4. The Urology Center of Colorado, Denver, Colorado. 5. Chesapeake Urology Research Associates, The Prostate Center, Owings Mills, Maryland. 6. Arizona Oncology Services Foundation, Phoenix, Arizona. 7. Urological Surgeons of Northern California, Campbell, California. 8. The Research Foundation of State University of New York, SUNY Upstate Medical University, Syracuse, New York. 9. Peninsula Cancer Center, Poulsbo, Washington. 10. Urology Nevada, Reno, Nevada. 11. University Hospitals Case Medical Center, Cleveland, Ohio. 12. Sutter Health Sacramento Sierra Region, Sutter Institute for Medical Research, Sacramento, California. 13. Advanced Radiation Centers of New York, Lake Success, New York. 14. Oregon Urology Institute, Springfield, Oregon. 15. University of Rochester, Rochester, New York. 16. CentraState Medical Center, Freehold, New Jersey. 17. Carolina Regional Cancer Center, 21st Century Oncology, Myrtle Beach, South Carolina. 18. 21st Century Oncology, Fort Meyers, Florida. 19. Emory University, Atlanta, Georgia. 20. The Johns Hopkins University, Baltimore, Maryland. 21. Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan. 22. Washington University School of Medicine, St. Louis, Missouri.
Abstract
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 underwentcomputed 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 rectal 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.
RCT Entities:
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 rectal 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.
Authors: Mitchell S Anscher; Michael G Chang; Drew Moghanaki; Mihaela Rosu; Ross B Mikkelsen; Diane Holdford; Vicki Skinner; Baruch M Grob; Arun Sanyal; Aiping Wang; Nitai D Mukhopadhyay Journal: Am J Clin Oncol Date: 2018-06 Impact factor: 2.339
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