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临床试验/NCT01825642
NCT01825642已完成2 期

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

University of Michigan2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2006年9月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
140
试验地点
2
主要终点
Mean sexual function domain score of the two groups as measured by the Expanded Prostate Cancer Index Composite

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 12 months

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brent Hollenbeck

Associate Professor, Urology

University of Michigan

研究点 (2)

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