Clinical Trial of Approaches to Prostate Cancer Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical TrIAL of Approaches to Prostate cAncer suRgery

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Robot-assisted radical prostatectomy (RP)
* Procedure: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male sex 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 Exclusion Criteria: Prior major pelvic surgery or radiotherapy Suspicion of N1 disease (i.e., any lymph node greater than 1cm in maximal diameter)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robot-assisted radical prostatectomy (RP)<br>The conventional robotic-assisted radical prostatectomy is the gold standard approach to prostate cancer surgery. | Procedure: Robot-assisted radical prostatectomy (RP)<br>* The conventional approach to prostate cancer surgery<br>|
| Experimental: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)<br>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. | Procedure: Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)<br>* A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Margin Status as assessed by surgical pathology results | Presence of cancer cells at the prostate margin is standardized as a positive surgical margin through professional guideline consensus. | 1 week post-surgery | 
| Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) | 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. | 6 months post-surgery | 
| Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) | Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL. | 12 months post-surgery | 
| Biochemical Recurrence as assessed by Prostate Specific Antigen (PSA) | Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL. | 24 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgery-Related Adverse Events as assessed by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) | The questionnaire will include 20 items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), survey items pertinent to short-stay cancer surgery. The questionnaire will assess patient-reported complications and adverse events, such as constipation, nausea and vomiting, fever, chills, fatigue, pain, shortness of breath, swelling and bruising, redness and discharge at the surgical incision site, anxiety, and flatulence (ileus). It will also assess patient contacts with physicians and admittance to urgent care or the emergency room. | 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) | The Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) is a 7-item questionnaire assessing two health-related quality of life domains: urinary and sexual function. All questions refer to patients' health and symptoms in the last four weeks. Each domain is scored out of 12 points, with higher scores indicating more complications. In total, the EPIC-CP score is the final sum of the two domains, with higher scores indicating more issues related to overall prostate cancer quality of life. | 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 | This is a 5-item questionnaire, published in the New England Journal of Medicine (NEJM), that has face validity for assessing penile shortening, self-esteem, and erectile function after radical prostatectomy. Question 1 assesses patients' perceived penile length post-surgery, compared to penile length at 30 years of age. It consists of two possible responses: Yes or No. Questions 2 and 3 assesses patients' ability to obtain and quality of spontaneous morning erections and sexual activity-related erections. It consists of five possible responses: ranging from No erections to Erections always sufficient. Question 4 is a visual digital scale assessing patients' present quality of life. It is scored on a scale of 1-7, with higher scores indicating high quality of life. Question 5 is a visual digital scale assessing patients' present self-esteem. It is scored on a scale of 1-7, with higher scores indicating high self-esteem. | Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery | 
| Change in patient-Reported Penile Curvature/Deformity (Peyronie's Disease), as measured by a 3-item questionnaire | This is a validated, 3-item questionnaire assessing presence of Peyronie's disease. The penile deformity items were validated by blinded clinical examination with 100% sensitivity and 99.4% specificity. Question 1 assesses penile hardening/plaques in the flaccid state. Question 2 assesses penile curvature in the erect state. Question 3 assesses pain associated with erection. Each question consists of two possible responses: Yes or No. | Baseline, 1 month, 6 months, 12 months, and 24 months post-surgery | 
| Patient-reported Decision Regret, as measured by a 5-item questionnaire | This is a 5-item questionnaire assessing treatment regret that was developed and validated in men with prostate cancer. Each item is scored on a 5 point scale ranging from Strongly Agree to Strongly Disagree. Responses are converted to a score ranging from 0-100, with higher scores indicating more regret. | 12 months post-surgery | 
| Patient-reported Decision Regret, as measured by a 5-item questionnaire | This is a 5-item questionnaire assessing treatment regret that was developed and validated in men with prostate cancer. | 24 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radical prostatectomy, nerve sparing, Retzius sparing