Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

The conventional robotic-assisted radical prostatectomy is the gold standard approach to prostate cancer surgery.

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.

The conventional approach to prostate cancer surgery

Robot-assisted radical prostatectomy (RP)

A novel, posterior approach to radical prostatectomy that preserves the dorsal vascular complex, nerves and fascial support structures that overlie the anterior prostate.

Pelvic fascia-sparing robot-assisted radical prostatectomy (PFS-RP)

Jim C Hu, MD MPH

Bouchra S Benghomari, BS

Keith Kowalczyk, MD

Mary Kate Keeter, MPH

Edward M Schaeffer, MD PhD

Rana Harb, MS

Mohamad E Allaf, MD

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.

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.

Outcomes assessors (i.e., pathologists) will be blinded to randomization.

Clinical Trial of Approaches to Prostate Cancer Surgery

Clinical TrIAL of Approaches to Prostate cAncer suRgery

Presence of cancer cells at the prostate margin is standardized as a positive surgical margin through professional guideline consensus.

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.

Prostate specific antigen (PSA) levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.

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.

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.

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.

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.

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.

This is a 5-item questionnaire assessing treatment regret that was developed and validated in men with prostate cancer.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Weill Medical College of Cornell University

Symptoms and General Pathology

Behaviors and Mental Disorders

Urinary Incontinence

Enuresis

Quality of Life

Using the Retzius technique, the surgeon will remove the prostate in a way that preserves a portion of the nerves and tissue structures that are typically removed during the conventional technique.

A non-Retzius nerve sparing technique will be performed, according to surgeon's preference--nerve sparing during radical prostatectomy is performed with significant variation and there is an absence of universally agreed upon steps or techniques.

Retzius nerve sparing is a specific approach that avoids disrupting the structures involved in urinary and sexual function.

Retzius sparing

The investigators propose a prospective study to assess recovery of urinary and sexual function by nerve sparing techniques after radical prostatectomy.

Subjects will be randomized in a 1:1 ratio to Retzius nerve sparing versus non-Retzius nerve sparing to compare cancer outcomes and urinary/sexual outcomes following radical prostatectomy. Using the Retzius technique, the surgeon will remove the prostate in a way that preserves a portion of the nerves and tissue structures that are typically removed during the conventional technique.

The investigators will assess recovery of urinary and sexual function of patients through questionnaires at 1 week, 1 month, 6 months, 12 months, and 24 months after surgery.

Randomized controlled trial comparing Retzius sparing robot-assisted radical prostatectomy versus conventional robot-assisted radical prostatectomy

A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy

Individual participant data (IPD) will not be shared with other researchers.

The investigators will obtain patient-reported complications and adverse events captured from patient's medical record.

Patients will fill out the EPIC-CP questionnaire. The EPIC-CP is a 10-item questionnaire assessing five health-related quality of life domains: urinary function, urinary irritation, bowel function, sexual function, and hormonal issues. All questions are about 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 5 domains. The EPIC-CP is scored out of 60 points, with higher scores indicating more issues related to overall prostate cancer quality of life.

The investigators will obtain patient's PSA values from their medical record, at baseline and up to 24 months post-surgery. Patient PSA levels are obtained from standard of care blood tests, and PSA values are measured in ng/mL.

Patients will fill out a validated, 5-item questionnaire assessing penile shortening, self-esteem, and presence of erections.

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.

Patients will fill out a validated, 3-item questionnaire assessing presence of Peyronie's disease.

Question 1 assesses penile hardening 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.

Patients will fill out a validated, 5-item questionnaire assessing feelings toward treatment regret.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial of Approaches to Prostate Cancer Surgery	NCT05155501	Prostate Cancer	Robot-assisted ... Pelvic fascia-s...	40 Years - 80 Years	Weill Medical College of Cornell University
Clinical Trial of Approaches to Prostate Cancer Surgery	NCT05155501	Prostate Cancer	Robot-assisted ... Pelvic fascia-s...	40 Years - 80 Years	Weill Medical College of Cornell University
Clinical Trial of Approaches to Prostate Cancer Surgery	NCT05155501	Prostate Cancer	Robot-assisted ... Pelvic fascia-s...	40 Years - 80 Years	Weill Medical College of Cornell University
A Prospective Trial on Nerve Sparing Techniques Performed in Radical Prostatectomy	NCT04393831	Prostate Cancer Quality of Life	Retzius sparing	40 Years - 80 Years	Weill Medical College of Cornell University
Clinical Trial of Approaches to Prostate Cancer Surgery	NCT05155501	Prostate Cancer	Robot-assisted ... Pelvic fascia-s...	40 Years - 80 Years	Weill Medical College of Cornell University

Spots Global Cancer Trial Database for retzius sparing