RecruitingNot ApplicableNCT06521710

Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assisted Radical Prostatectomy

Phase I Clinical Trial: Pilot Study of Intraoperative Somatic-Autonomic Nerve Grafting Technique to Preserve Erectile Function in Patients With High Grade Prostate Cancer Undergoing Robotic Assisted Radical Prostatectomy


Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Enrollment

10 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The investigator proposing a single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing Nerve Restoring (NR) Robotically assisted laparoscopic radical prostatectomy (RALP). During this study a total of 10 patients who are undergoing robotic prostatectomy will have their surgery performed utilizing a novel technique, NR-RALP, which incorporates a genitofemoral (GFN) nerve graft designed to try to improve the erectile function and recovery of men undergoing standard of care robotic prostatectomy while minimizing additional morbidity of the procedure


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether grafting a small nerve (taken from elsewhere in the body) during robot-assisted radical prostatectomy can help preserve erectile function in men with high-risk prostate cancer. **You may be eligible if...** - You are 18 or older - You are scheduled for robotic prostate removal for high-risk localized prostate cancer (Gleason score ≥8, PSA ≥20, or tumor larger than T2 on MRI) - You currently have good erectile function before surgery (IIEF score ≥17) **You may NOT be eligible if...** - You have previously had pelvic surgery or pelvic radiation - You have previously had focal therapy for prostate cancer - You have a pre-existing neurological disease - You are having surgery for another cancer at the same time - You are unable to complete questionnaires and have no caregiver to assist Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIntraoperative Somatic-Autonomic Nerve Grafting

A one-sided graft using a genitofemoral (GFN) nerve graft between one obturator nerve and the corpora cavernosa


Locations(2)

Jewish General Hospital, CIUSSS Centre-Ouest de l'île de Montréal

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

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NCT06521710


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