Clinical TrIAL of Approaches to Prostate cAncer suRgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 14
- 主要终点
- Surgical Margin Status as assessed by surgical pathology results
研究概览
简要总结
This is a prospective, randomized controlled trial to compare cancer control and health-related quality of life following pelvic fascia-sparing radical prostatectomy versus standard radical prostatectomy.
The investigators hypothesize that pelvic fascia-sparing radical prostatectomy will have similar cancer control (primary outcome) and sexual function outcomes; and significantly better urinary function, penile shortening/deformity and inguinal hernia risks as compared to radical prostatectomy.
详细描述
Traditional radical prostatectomy is the most popular treatment for clinically significant prostate cancer, however significant risks including urinary incontinence, erectile dysfunction, penile shortening, penile curvature/ deformation (Peyronie's disease), and inguinal hernia, are common. Pelvic fascia-sparing radical prostatectomy is a new surgical technique that may preserve fascial support structures, arterial supply to the penis, and nerves that are severed and resected during conventional radical prostatectomy.
This study will enroll adult men undergoing radical prostatectomy for clinically localized prostate cancer. Subjects will be randomized to receive either radical prostatectomy or pelvic fascia-sparing radical prostatectomy. Investigators will compare cancer control and health-related quality of life outcomes through patient questionnaires and medical record review.
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 (Outcomes Assessor)
盲法说明
Outcomes assessors (i.e., pathologists) will be blinded to randomization.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥40 years or ≤80 years
- •Scheduled for radical prostatectomy for clinically localized prostate cancer
- •Able to read and speak English or Spanish
- •Willingness to sign informed consent and adhere to the study protocol
排除标准
- •Prior major pelvic surgery or radiotherapy
- •Suspicion of N1 disease (i.e., any lymph node greater than 1cm in maximal diameter)
研究组 & 干预措施
Robot-assisted radical prostatectomy (RP)
The conventional robotic-assisted radical prostatectomy is the gold standard approach to prostate cancer surgery.
干预措施: Robot-assisted radical prostatectomy (RP) (Procedure)
Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)
A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate. These structures are disrupted and removed during conventional radical prostatectomy.
干预措施: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP) (Procedure)
结局指标
主要结局
Surgical Margin Status as assessed by surgical pathology results
时间窗: 1 week post-surgery
Presence of cancer cells at the prostate margin is standardized as a positive surgical margin through professional guideline consensus.
Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)
时间窗: 24 months post-surgery
Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.
Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)
时间窗: 6 months post-surgery
Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL. In accordance with National Comprehensive Cancer Network (NCCN) guidelines, investigators will capture PSA persistence as failure of PSA to fall to undetectable levels, and PSA recurrence as an undetectable PSA after surgery with a subsequent detectable PSA that increases on 2 or more determinations.
Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA)
时间窗: 12 months post-surgery
Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.
次要结局
- Surgery-Related Adverse Events as assessed by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)(Up to 30 days following surgery)
- Change in Urinary and Sexual Function, as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)(Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery)
- Change in Patient-Reported Penile Shortening and Sexual Function, as measured by a 5-item questionnaire(Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery)
- Patient-reported Decision Regret, as measured by a 5-item questionnaire(24 months post-surgery)
- Change in patient-Reported Penile Curvature/Deformity (Peyronie's Disease), as measured by a 3-item questionnaire(Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery)
- Patient-reported Decision Regret, as measured by a 5-item questionnaire(12 months post-surgery)