Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06521710

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

Led by Sir Mortimer B. Davis - Jewish General Hospital · Updated on 2024-09-19

10

Participants Needed

2

Research Sites

169 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing standard of care robotic radical prostatectomy for high-risk localized prostate cancer defined by any of: Gleason grade 658, PSA 6520, or greater than pT2 on preoperative MRI imaging
  • Patients must have preoperative erectile function with a baseline IIEF score of 6517
Not Eligible

You will not qualify if you...

  • Previous pelvic surgery
  • Previous pelvic radiotherapy
  • Previous focal therapy for prostate cancer
  • Age under 18 years at diagnosis
  • Legally incapable patients
  • Unable to complete questionnaires without a companion to assist
  • Undergoing concomitant cancer surgery
  • Pre-existing neurologic disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

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

Montreal, Quebec, Canada, H3T 1E2

Actively Recruiting

2

Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

Actively Recruiting

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Research Team

V

Victor McPherson, MD

CONTACT

O

Oleg Loutochin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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