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

Phase 2/Phase 3
18 Years
Not Enrolling
Prostate Cancer

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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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Mean sexual function domain score of the two groups as measured by the Expanded Prostate Cancer Index Composite

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Brent Hollenbeck, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Institutional Review Board

Study ID:




Start Date:

September 2006

Completion Date:

December 2012

Related Keywords:

  • Prostate Cancer
  • Prostate cancer
  • sexual function
  • seminal vesicle sparing
  • nerve-sparing
  • radical prostatectomy
  • Prostatic Neoplasms



University of MichiganAnn Arbor, Michigan  48109-0624