Prospective Randomized Trial of Seminal Vesicle-Sparing Prostatectomy and Nerve-Sparing Radical Prostatectomy in Men With Clinically Localized Prostate Cancer
Prospective Randomized Trial of Seminal Vesicle-Sparing Prostatectomy and Nerve-Sparing Radical Prostatectomy in Men With Clinically Localized Prostate Cancer
Surgical removal of the prostate (radical prostatectomy) is a common and generally effective
 treatment for prostate cancer. However, standard prostatectomy can affect urinary continence
 and sexual function. Different surgical techniques, such as nerve-sparing prostatectomy and
 seminal vesicle-sparing prostatectomy, may limit these treatment-related effects. In a
 standard prostatectomy, the seminal vesicles are removed completely. In contrast, during a
 seminal vesicle-sparing prostatectomy, the surgeon leaves a portion of the seminal vesicles
 intact. This is done because the nerves that are important to urinary continence and erectile
 function are located close to the seminal vesicles. The purpose of this study is to determine
 whether patients who undergo nerve-sparing prostatectomy with seminal vesicle-sparing
 experience better urinary and sexual functioning after surgery than patients who undergo
 standard nerve-sparing prostatectomy.
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.
Inclusion Criteria:

 -  Men with biopsy-proven histologic diagnosis of prostate adenocarcinoma

 -  Low risk for seminal vesicle invasions defined by:

 Clinical stage T1c/tumor 2-node 0-metastasis 0, Gleason score ≤ 6, PSA ≤ 10 ng/ml, positive
 prostate biopsy core proportion ≤ 1/2 (50%) or clinical stage T1c/T2N0M0, Gleason ≤ 7, PSA
 ≤ 6 ng/ml, positive biopsy core proportion ≤ 1/3 (33.3%)

 -  Sexually potent, defined as International Index of Erectile Function score ≥ 21, prior
 to randomization and surgery

 -  Competent to provide informed consent

 -  Able to read and write English

 -  Candidate for bilateral nerve-sparing

 -  Willing to be followed for 12 months post-surgery

 Exclusion Criteria:

 -  Intermediate or high risk for seminal vesicle invasion

 -  Unwilling to be randomized to either treatment arm

 -  Pre-operative treatment with radiation and/or hormone therapy

 -  Planned adjuvant radiation and/or hormonal therapy