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

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ClinicalTrials.gov Identifier: NCT01825642
Recruitment Status : Completed
First Posted : April 5, 2013
Last Update Posted : April 5, 2013
Sponsor:
Information provided by (Responsible Party):
Brent Hollenbeck, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Procedure: nerve-sparing radical prostatectomy Procedure: seminal vesicle-sparing radical prostatectomy Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Seminal Vesicle-Sparing Prostatectomy and Nerve-Sparing Radical Prostatectomy in Men With Clinically Localized Prostate Cancer
Study Start Date : September 2006
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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



Primary Outcome Measures :
  1. Mean sexual function domain score of the two groups as measured by the Expanded Prostate Cancer Index Composite [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Mean urinary incontinence domain score of the two groups as measured by the Expanded Prostate Cancer Index Composite [ Time Frame: 12 months ]
  2. % positive surgical margin, mean PSA nadir, and % PSA >= 0.2 ng/cc or higher between the 2 groups [ Time Frame: 12 months ]
  3. % complications between 2 groups [ Time Frame: 12 months ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825642


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Brent Hollenbeck, M.D. University of Michigan

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Responsible Party: Brent Hollenbeck, Associate Professor, Urology, University of Michigan
ClinicalTrials.gov Identifier: NCT01825642     History of Changes
Other Study ID Numbers: HUM00005063
First Posted: April 5, 2013    Key Record Dates
Last Update Posted: April 5, 2013
Last Verified: April 2013
Keywords provided by Brent Hollenbeck, University of Michigan:
Prostate cancer
sexual function
seminal vesicle sparing
nerve-sparing
radical prostatectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Blister
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Skin Diseases, Vesiculobullous
Skin Diseases
Pathological Conditions, Anatomical