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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: nerve-sparing radical prostatectomy; Procedure: seminal vesicle-sparing radical prostatectomy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; nerve-sparing radical prostatectomy	Procedure: nerve-sparing radical prostatectomy
Active Comparator: Treatment Group; seminal vesicle-sparing radical prostatectomy	Procedure: seminal vesicle-sparing radical prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean sexual function domain score of the two groups as measured by the Expanded Prostate Cancer Index Composite	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean urinary incontinence domain score of the two groups as measured by the Expanded Prostate Cancer Index Composite		12 months
% positive surgical margin, mean PSA nadir, and % PSA >= 0.2 ng/cc or higher between the 2 groups		12 months
% complications between 2 groups	Complications were defined as possible or anticipated adverse events related to or likely related to the surgery (prostatectomy), such as urinary complications (urine leak, obstruction, incontinence, infection, bladder neck contracture), surgical complications (wound dehiscence, hernia, bleeding, rectal injury, ileus, anastomotic disruption, l;ymphocele), infectious complication (C difficile colitis, abscess, pneumonia) and general medical complications (pulmonary embolism, stroke, myocardial infarction, deep vein thrombosis).	12 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Brent Hollenbeck, M.D., University of Michigan

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 19, 2013
• First Submitted That Met QC Criteria: April 1, 2013
• First Posted (Estimate): April 5, 2013

Study Record Updates

• Last Update Posted (Estimate): April 5, 2013
• Last Update Submitted That Met QC Criteria: April 1, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Prostate cancer; sexual function; radical prostatectomy; seminal vesicle sparing; nerve-sparing
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: HUM00005063