Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer: Secondary analysis of a phase 3 trial

Daniel A Hamstra; Neil Mariados; John Sylvester; Dhiren Shah; Eric Gross; Richard Hudes; David Beyer; Steven Kurtzman; Jeffrey Bogart; R Alex Hsi; Michael Kos; Rodney Ellis; Mark Logsdon; Shawn Zimberg; Kevin Forsythe; Hong Zhang; Edward Soffen; Patrick Francke; Constantine Mantz; Peter Rossi; Theodore DeWeese; Stephanie Daignault-Newton; Benjamin W Fischer-Valuck; Anupama Chundury; Hiram A Gay; Walter Bosch; Jeff Michalski

doi:10.1016/j.prro.2017.07.008

Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer: Secondary analysis of a phase 3 trial

Pract Radiat Oncol. 2018 Jan-Feb;8(1):e7-e15. doi: 10.1016/j.prro.2017.07.008. Epub 2017 Jul 19.

Authors

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

Affiliations

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.

PMID: 28951089
DOI: 10.1016/j.prro.2017.07.008

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.

Publication types

Clinical Trial, Phase III

MeSH terms

Humans
Male
Prostatic Neoplasms / radiotherapy*
Quality of Life / psychology*
Radiotherapy, Intensity-Modulated / methods
Radiotherapy, Intensity-Modulated / psychology*
Sexual Behavior / psychology*