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 J. Ellis, Mark Logsdon, Shawn Zimberg, Kevin Forsythe, Hong Zhang, Edward Soffen, Patrick Francke, Constantine Mantz, Peter Rossi & 7 others Theodore DeWeese, Stephanie Daignault-Newton, Benjamin W. Fischer-Valuck, Anupama Chundury, Hiram A. Gay, Walter Bosch, Jeff Michalski

Research output: Contribution to journalArticle

10 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)e7-e15
JournalPractical Radiation Oncology
Volume8
Issue number1
DOIs
StatePublished - Jan 1 2018

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Prostate
Radiotherapy
Quality of Life
Hydrogel
Prostatic Neoplasms
Control Groups
Minimal Clinically Important Difference

All Science Journal Classification (ASJC) codes

  • Oncology
  • Radiology Nuclear Medicine and imaging

Cite this

Hamstra, Daniel A. ; Mariados, Neil ; Sylvester, John ; Shah, Dhiren ; Gross, Eric ; Hudes, Richard ; Beyer, David ; Kurtzman, Steven ; Bogart, Jeffrey ; Hsi, R. Alex ; Kos, Michael ; Ellis, Rodney J. ; Logsdon, Mark ; Zimberg, Shawn ; Forsythe, Kevin ; Zhang, Hong ; Soffen, Edward ; Francke, Patrick ; Mantz, Constantine ; Rossi, Peter ; DeWeese, Theodore ; Daignault-Newton, Stephanie ; Fischer-Valuck, Benjamin W. ; Chundury, Anupama ; Gay, Hiram A. ; Bosch, Walter ; Michalski, Jeff. / Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer : Secondary analysis of a phase 3 trial. In: Practical Radiation Oncology. 2018 ; Vol. 8, No. 1. pp. e7-e15.
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title = "Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer: Secondary analysis of a phase 3 trial",
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.",
author = "Hamstra, {Daniel A.} and Neil Mariados and John Sylvester and Dhiren Shah and Eric Gross and Richard Hudes and David Beyer and Steven Kurtzman and Jeffrey Bogart and Hsi, {R. Alex} and Michael Kos and Ellis, {Rodney J.} and Mark Logsdon and Shawn Zimberg and Kevin Forsythe and Hong Zhang and Edward Soffen and Patrick Francke and Constantine Mantz and Peter Rossi and Theodore DeWeese and Stephanie Daignault-Newton and Fischer-Valuck, {Benjamin W.} and Anupama Chundury and Gay, {Hiram A.} and Walter Bosch and Jeff Michalski",
year = "2018",
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language = "English (US)",
volume = "8",
pages = "e7--e15",
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Hamstra, DA, Mariados, N, Sylvester, J, Shah, D, Gross, E, Hudes, R, Beyer, D, Kurtzman, S, Bogart, J, Hsi, RA, Kos, M, Ellis, RJ, Logsdon, M, Zimberg, S, Forsythe, K, Zhang, H, Soffen, E, Francke, P, Mantz, C, Rossi, P, DeWeese, T, Daignault-Newton, S, Fischer-Valuck, BW, Chundury, A, Gay, HA, Bosch, W & Michalski, J 2018, 'Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer: Secondary analysis of a phase 3 trial', Practical Radiation Oncology, vol. 8, no. 1, pp. e7-e15. https://doi.org/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. / Hamstra, Daniel A.; Mariados, Neil; Sylvester, John; Shah, Dhiren; Gross, Eric; Hudes, Richard; Beyer, David; Kurtzman, Steven; Bogart, Jeffrey; Hsi, R. Alex; Kos, Michael; Ellis, Rodney J.; Logsdon, Mark; Zimberg, Shawn; Forsythe, Kevin; Zhang, Hong; Soffen, Edward; Francke, Patrick; Mantz, Constantine; Rossi, Peter; DeWeese, Theodore; Daignault-Newton, Stephanie; Fischer-Valuck, Benjamin W.; Chundury, Anupama; Gay, Hiram A.; Bosch, Walter; Michalski, Jeff.

In: Practical Radiation Oncology, Vol. 8, No. 1, 01.01.2018, p. e7-e15.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer

T2 - Secondary analysis of a phase 3 trial

AU - Hamstra, Daniel A.

AU - Mariados, Neil

AU - Sylvester, John

AU - Shah, Dhiren

AU - Gross, Eric

AU - Hudes, Richard

AU - Beyer, David

AU - Kurtzman, Steven

AU - Bogart, Jeffrey

AU - Hsi, R. Alex

AU - Kos, Michael

AU - Ellis, Rodney J.

AU - Logsdon, Mark

AU - Zimberg, Shawn

AU - Forsythe, Kevin

AU - Zhang, Hong

AU - Soffen, Edward

AU - Francke, Patrick

AU - Mantz, Constantine

AU - Rossi, Peter

AU - DeWeese, Theodore

AU - Daignault-Newton, Stephanie

AU - Fischer-Valuck, Benjamin W.

AU - Chundury, Anupama

AU - Gay, Hiram A.

AU - Bosch, Walter

AU - Michalski, Jeff

PY - 2018/1/1

Y1 - 2018/1/1

N2 - 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.

AB - 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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DO - 10.1016/j.prro.2017.07.008

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