Daniel A Hamstra1, Neil Mariados2, John Sylvester3, Dhiren Shah4, Eric Gross5, Richard Hudes6, David Beyer7, Steven Kurtzman8, Jeffrey Bogart9, R Alex Hsi10, Michael Kos11, Rodney Ellis12, Mark Logsdon13, Shawn Zimberg14, Kevin Forsythe15, Hong Zhang16, Edward Soffen17, Patrick Francke18, Constantine Mantz19, Peter Rossi20, Theodore DeWeese21, Stephanie Daignault-Newton22, Benjamin W Fischer-Valuck23, Anupama Chundury23, Hiram A Gay23, Walter Bosch23, Jeff Michalski23. 1. The Department of Radiation Oncology, Beaumont Hospital, Dearborn, Michigan. Electronic address: Daniel.Hamstra@Beaumont.org. 2. Associated Medical Professionals of NY PLLC, Syracuse, New York. 3. 21st Century Oncology, Inc., Lakewood Ranch, East Bradenton, Florida. 4. Western New York Urology Associates, LLC /D/B/A Cancer Care of WNY, Cheektowaga, New York. 5. The Urology Center of Colorado, Denver, Colorado. 6. Chesapeake Urology Associates d/b/a Chesapeake Urology Research Associates (The Prostate Center), Owings Mills, Maryland. 7. Cancer Centers of Northern Arizona, Sedona, Arizona. 8. Urological Surgeons of Northern California Inc., Campbell, California. 9. The Research Foundation of State University of New York/SUNY Upstate Medical University, Syracuse, New York. 10. Peninsula Cancer Center, Poulsbo, Washington. 11. Northern Nevada Radiation Oncology, Reno, Nevada. 12. University Hospitals Case Medical Center, Cleveland, Ohio. 13. Sutter Health Sacramento Sierra Region d/b/a Sutter Institute for Medical Research, Sacramento, California. 14. Advanced Radiation Centers of New York, Lake Success, New York. 15. Oregon Urology Institute, Springfield, Oregon. 16. University of Rochester, Rochester, New York. 17. CentraState Medical Center, Freehold, New Jersey. 18. Carolina Regional Cancer Center, LLC/21st Century Oncology, Inc., Myrtle Beach, South Carolina. 19. 21st Century Oncology, Inc., Fort Meyers, Florida. 20. Emory University, Atlanta, Georgia. 21. The Johns Hopkins University, Baltimore, Maryland. 22. Department of Biostatistics, University of Michigan, Ann Arbor, Michigan. 23. Washington University School of Medicine, St. Louis, Missouri.
Abstract
BACKGROUND: We previously reported the results of a phase 3 trial evaluating a prostate/rectal hydrogel spacer during prostate intensity modulated radiation therapy, which resulted in decreased rectal dose and toxicity and less decline in bowel quality of life (QOL). A secondary analysis was performed to correlate penile bulb dose and sexual QOL. METHODS AND MATERIALS: Sexual QOL was measured with the Expanded Prostate Cancer Index Composite (EPIC) by mean scores, the proportion of patients with a minimal clinically important difference (MID), and analyses of the different items composing the sexual domain. RESULTS: A total of 222 men enrolled with median follow-up of 37 months. Hydrogel reduced penile bulb mean dose, maximum dose, and percentage of penile bulb receiving 10 to 30 Gy (all P < .05) with mean dose indirectly correlated with erections sufficient for intercourse at 15 months (P = .03). Baseline EPIC was low (53 [standard deviation ± 24]) with no difference between arms (P > .1). A total of 41% (88/222) of men had adequate baseline sexual QOL (EPIC >60 (mean, 77 [± 8.3]). This subgroup at 3 years had better sexual function (P = .03) with a spacer with a smaller difference in sexual bother (P = .1), which resulted in a higher EPIC summary on the spacer arm (58 [±24.1] vs control 45 [± 24.4]) meeting threshold for MID without statistical significance (P = .07). There were statistically nonsignificant differences favoring spacer for the proportion of men with MID and 2× MID declines in sexual QOL with 53% vs 75% having an 11-point decline (P = .064) and 41% vs 60% with a 22-point decline (P = .11). At 3 years, more men potent at baseline and treated with spacer had "erections sufficient for intercourse" (control 37.5% vs spacer 66.7%, P = .046) as well as statistically higher scores on 7 of 13 items in the sexual domain (all P < .05). CONCLUSIONS: The use of a hydrogel spacer decreased dose to the penile bulb, which was associated with improved erectile function compared with the control group based on patient-reported sexual QOL.
RCT Entities:
BACKGROUND: We previously reported the results of a phase 3 trial evaluating a prostate/rectal hydrogel spacer during prostate intensity modulated radiation therapy, which resulted in decreased rectal dose and toxicity and less decline in bowel quality of life (QOL). A secondary analysis was performed to correlate penile bulb dose and sexual QOL. METHODS AND MATERIALS: Sexual QOL was measured with the Expanded Prostate Cancer Index Composite (EPIC) by mean scores, the proportion of patients with a minimal clinically important difference (MID), and analyses of the different items composing the sexual domain. RESULTS: A total of 222 men enrolled with median follow-up of 37 months. Hydrogel reduced penile bulb mean dose, maximum dose, and percentage of penile bulb receiving 10 to 30 Gy (all P < .05) with mean dose indirectly correlated with erections sufficient for intercourse at 15 months (P = .03). Baseline EPIC was low (53 [standard deviation ± 24]) with no difference between arms (P > .1). A total of 41% (88/222) of men had adequate baseline sexual QOL (EPIC >60 (mean, 77 [± 8.3]). This subgroup at 3 years had better sexual function (P = .03) with a spacer with a smaller difference in sexual bother (P = .1), which resulted in a higher EPIC summary on the spacer arm (58 [±24.1] vs control 45 [± 24.4]) meeting threshold for MID without statistical significance (P = .07). There were statistically nonsignificant differences favoring spacer for the proportion of men with MID and 2× MID declines in sexual QOL with 53% vs 75% having an 11-point decline (P = .064) and 41% vs 60% with a 22-point decline (P = .11). At 3 years, more men potent at baseline and treated with spacer had "erections sufficient for intercourse" (control 37.5% vs spacer 66.7%, P = .046) as well as statistically higher scores on 7 of 13 items in the sexual domain (all P < .05). CONCLUSIONS: The use of a hydrogel spacer decreased dose to the penile bulb, which was associated with improved erectile function compared with the control group based on patient-reported sexual QOL.
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