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

Completed · Phase 2/Phase 3

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01825642

Run by

University of Michigan

People needed

140

Starts

2006-09-01

Expected to finish

2012-12-01

Last updated by the study team

2013-04-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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