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

作者：Daniel A. Hamstra, Neil Mariados, John Sylvester, Dhiren Shah, Eric Gross, Richard Hudes, David Beyer, Steven Kurtzman, Jeffrey A. Bogart, R.A. Hsi, Michael Kos, Rodney J. Ellis, Mark D. Logsdon, S.H. Zimberg, Kevin Forsythe, Hong Zhang, Edward Soffen, Patrick Francke, C.A. Mantz, Peter J. Rossi, Theodore L. DeWeese, Stephanie Daignault‐Newton, Benjamin W. Fischer‐Valuck, Anupama Chundury, Hiram A. Gay, Walter Bosch, Jeff M. Michalski · 发表于：Practical Radiation Oncology · 年份：2017 · DOI：10.1016/j.prro.2017.07.008 · 被引用次数：64 · 研究领域：Prostate Cancer Diagnosis and Treatment、Effects of Radiation Exposure、Advanced Radiotherapy Techniques

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 ...