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

NCT01825642 | Completed Phase 2 DMC

• 1 other identifier: HUM00005063
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; sexual function; seminal vesicle sparing; nerve-sparing; radical prostatectomy

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (3)

• 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

  12 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

nerve-sparing radical prostatectomy

Procedure: nerve-sparing radical prostatectomy

Treatment Group

ACTIVE COMPARATOR

seminal vesicle-sparing radical prostatectomy

Procedure: seminal vesicle-sparing radical prostatectomy

Interventions

nerve-sparing radical prostatectomy PROCEDURE

Control Group

seminal vesicle-sparing radical prostatectomy PROCEDURE

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Brent Hollenbeck, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Urology

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: April 5, 2013
• Study Start: September 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 5, 2013

Record last verified: 2013-04

Locations

US (1)