The Effect of Nerve Sparing Status on Sexual and Urinary Function: 3-Year Results from the CEASAR Study.

PURPOSE: Nerve sparing contributes to the recovery of sexual and urinary function after radical prostatectomy but it may be ineffective in some patients or carry the risk of a positive surgical margin. We evaluated sexual and urinary function outcomes according to the degree of nerve sparing in patients with prostate cancer treated with radical prostatectomy. MATERIALS AND METHODS: The CEASAR (Comparative Effectiveness Analysis of Surgery and Radiation) study is a prospective, population based, observational study of men diagnosed with localized prostate cancer in 2011 to 2012. Patient reported sexual and urinary functions were measured using the 26-item Expanded Prostate Index Composite at baseline within 6 months after diagnosis, and 6, 12 and 36 months after enrollment. Study inclusion criteria included radical prostatectomy as primary treatment, documentation of nerve sparing status and absent androgen deprivation therapy. Nerve sparing status was defined as none, unilateral or bilateral according to the operative report. RESULTS: The final analytical cohort included 991 men. The 11 men treated with unilateral nerve sparing and the 75 treated with a nonnerve sparing procedure were grouped together. In the multivariable model there was a significant difference in the sexual function score 3 years after radical prostatectomy in the bilateral nerve sparing group compared with the unilateral and nonnerve sparing group (6.1 points, 95% CI 2.0-10.3, p = 0.004). This was more pronounced in men with high baseline sexual function (8.23 points, 95% CI 1.6-14.8, p = 0.014) but not in those with low baseline function (4.0 points, 95% CI -0.6-8.7, p = 0.090). Similar effects were demonstrated on urinary incontinence scores. CONCLUSIONS: Bilateral nerve sparing resulted in better sexual and urinary function outcomes than unilateral or nonnerve sparing but the difference was not significant in men with low baseline sexual function.

The Comparative Harms of Open and Robotic Prostatectomy in Population Based Samples.

PURPOSE: Robotic assisted radical prostatectomy has largely replaced open radical prostatectomy for the surgical management of prostate cancer despite conflicting evidence of superiority with respect to disease control or functional sequelae. Using population cohort data, in this study we examined sexual and urinary function in men undergoing open radical prostatectomy vs those undergoing robotic assisted radical prostatectomy. MATERIALS AND METHODS: Subjects surgically treated for prostate cancer were selected from 2 large population based prospective cohort studies, the Prostate Cancer Outcomes Study (enrolled 1994 to 1995) and the Comparative Effectiveness Analysis of Surgery and Radiation (enrolled 2011 to 2012). Subjects completed baseline, 6-month and 12-month standardized patient reported outcome measures. Main outcomes were between-group differences in functional outcome scores at 6 and 12 months using linear regression, and adjusting for baseline function, sociodemographic and clinical characteristics. Sensitivity analyses were used to evaluate outcomes between patients undergoing open radical prostatectomy and robotic assisted radical prostatectomy within and across CEASAR and PCOS. RESULTS: The combined cohort consisted of 2,438 men, 1,505 of whom underwent open radical prostatectomy and 933 of whom underwent robotic assisted radical prostatectomy. Men treated with robotic assisted radical prostatectomy reported better urinary function at 6 months (mean difference 3.77 points, 95% CI 1.09-6.44) but not at 12 months (1.19, -1.32-3.71). Subjects treated with robotic assisted radical prostatectomy also reported superior sexual function at 6 months (8.31, 6.02-10.56) and at 12 months (7.64, 5.25-10.03). Sensitivity analyses largely supported the sexual function findings with inconsistent support for urinary function results. CONCLUSIONS: This population based study reveals that men undergoing robotic assisted radical prostatectomy likely experience less decline in early urinary continence and sexual function than those undergoing open radical prostatectomy. The clinical meaning of these differences is uncertain and longer followup will be required to establish whether these benefits are durable.

Patient Reported Comparative Effectiveness of Contemporary Intensity Modulated Radiation Therapy Versus External Beam Radiation Therapy of the Mid 1990s for Localized Prostate Cancer.

INTRODUCTION: Little is known about differences in patient reported outcomes between contemporary external beam radiation therapy for localized prostate cancer that delivers higher doses of conformal radiation and older techniques. We examined sexual, urinary and bowel function between men undergoing contemporary intensity modulated radiation therapy vs those undergoing external beam radiation therapy in the mid 1990s. METHODS: Subjects were selected from 2 large population based prospective cohort studies. Main outcomes were between-group differences in adjusted mean scores at 6 and 12 months. Secondary analyses examined odds ratios comparing groups reporting a clinically significant decline in function. RESULTS: The cohort consisted of 943 men, 467 diagnosed in 2011 to 2012 and 476 diagnosed in 1994 to 1995. Men undergoing contemporary intensity modulated radiation therapy reported better bowel function at 6 months (mean difference 4.3 points, 95% CI 1.6-7.0) but not at 12 months. Patients receiving contemporary intensity modulated radiation therapy reported statistically worse but probably not clinically meaningful different urinary function at 12 months (2.7, 0.5 to 4.8 points), and no difference at 6 months. No differences in sexual function at 6 or 12 months were found. Secondary analyses demonstrated lower odds of reporting clinically meaningful declines in bowel function at 6 and 12 months and sexual function at 12 months for contemporary intensity modulated radiation therapy. However, patients receiving intensity modulated radiation therapy had higher odds of reporting clinically meaningful declines in urinary continence at 12 months. CONCLUSIONS: Despite the delivery of higher doses of radiation, men treated with contemporary intensity modulated radiation therapy reported fewer gastrointestinal and possibly fewer sexual side effects than those treated with external beam radiation therapy in the mid 1990s. However, delivery of dose escalated intensity modulated radiation therapy may cause more urinary side effects.