Recruiting

Nerve Grafting

Sponsor:

Sir Mortimer B. Davis - Jewish General Hospital

Code:

NCT06521710

Conditions

Prostate Cancer

Erectile Dysfunction

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intraoperative Somatic-Autonomic Nerve Grafting

Study Details

Brief 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

Conditions

Prostate Cancer

Erectile Dysfunction

Study ID

NCT06521710

Start date

Sep, 2024

Status verified date

Sep, 2024

Completion date

Dec, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients undergoing standard of care robotic radical prostatectomy for high-risk localized prostate cancer as defined by any of:

1. Gleason grade ≥8
2. PSA ≥20
3. >pT2 on preoperative MRI imaging
2. Patients must have preoperative erectile function with a baseline IIEF score of ≥17

Exclusion Criteria:

1. Patients with previous pelvic surgery
2. Patients with previous pelvic radiotherapy
3. Patient with previous focal therapy for prostate cancer
4. Patients aged < 18 years at diagnosis
5. Legally incapable patients
6. Patients who are unable to complete questionnaires and have no companion to help complete them
7. Patients undergoing a concomitant cancer surgery
8. Patients with pre-existing neurologic disease

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NR-RALP

Nerve Grafting Technique in patients with High Grade Prostate Cancer Undergoing Robotic Assisted Radical Prostatectomy

Interventions

Intraoperative Somatic-Autonomic Nerve Grafting

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

Primary outcome measure

  • Adverse events measured by the Clavian-Dindo classification [ Time Frame: Through study completion, an average of 18 months ]

Central Contacts and Locations

Central contacts

Victor McPherson, MD

514-340-8222victor.mcpherson@mcgill.ca

Oleg Loutochin

514-340-8222oloutochin@jgh.mcgill.ca

Locations

Jewish General Hospital, CIUSSS Centre-Ouest de l&#39;île de Montréal

Recruiting

Montreal, Quebec, Canada, H3T 1E2

Contacts

Victor McPherson, MD

514-340-8222victor.mcpherson@mcgill.ca

Jewish General Hospital

Recruiting

Montréal, Quebec, Canada, H3T 1E2

Contacts

Victor McPherson, MD

514-340-8222victor.mcpherson@gmail.com

Oleg Loutochin

514-340-8222oloutochin@jgh.mcgill.ca

More Information

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Sir Mortimer B. Davis - Jewish General Hospital on 2024-09-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.