Trial Information

Prospective Randomized Trial of Seminal Vesicle-Sparing Prostatectomy and Nerve-Sparing Radical Prostatectomy in Men With Clinically Localized Prostate Cancer

Prostate cancer is the most common cancer diagnosed in men, and is increasingly managed with
effective treatment strategies, including surgery. Although active treatment provides
excellent cancer control, issues related to the functional and health-related quality of
life outcomes following treatment persist. Surgical therapy (radical prostatectomy) is a
commonly used treatment but is associated with erectile and sexual dysfunction, in addition
to urinary incontinence. Substantial efforts have been made to reduce rates of incontinence
and impotence following surgery. Nerve-sparing prostatectomy has been the most successful
technique for preserving erectile function in sexually active men; however, issues such as
the quality of the nerve-sparing, surgeon experience, and case complexity continue to impact
the outcomes of many men treated with radical prostatectomy. In addition, for patients with
low-risk, early-stage prostate cancer, there is currently debate regarding the extent of
dissection and tissue removal around the prostate. Specifically, the necessity of complete
removal of the seminal vesicles (paired structures located adjacent to the prostate and
posterior to the base of the bladder that are responsible for the majority of ejaculate
volume) is not clear. This is potentially important for functional and health-related
quality of life outcomes because the nerves responsible for erectile function course
immediately next to the seminal vesicles. Complete dissection and removal therefore risks
injury to these nerves, and may decrease the overall quality of nerve sparing during
prostatectomy. Our objective is to determine if seminal vesicle-sparing, in addition to
nerve-sparing, results in relatively preserved post-surgery functional and health-related
quality of life outcomes (erectile function and urinary continence) compared to
nerve-sparing alone in select patients with low-risk, early-stage prostate cancer treated
surgically with prostatectomy. In order to evaluate this objective, we will randomize a
series of men with recently diagnosed, low-risk, early-stage prostate cancer who choose
surgical therapy to either standard nerve-sparing prostatectomy or seminal vesicle-sparing
prostatectomy. We will then compare sexual and urinary function post-operatively to
determine if there is a difference in treatment approach.