Nerve grafting technique to help preserve erectile function after prostate surgery
Official title: 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
Run by Sir Mortimer B. Davis - Jewish General Hospital · NCT06521710 · Data updated 2026-11-12
This study is testing a new nerve grafting technique during prostate surgery to see if it can help men keep their erectile function after the operation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 10 (estimated) |
| Sponsor | Sir Mortimer B. Davis - Jewish General Hospital Academic / other |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Status | Recruiting |
| Started | September 2024 |
| Main results expected | September 2027 |
| Study ends | December 2027 |
| Registry record updated | September 19, 2024 |
| Trial ID | NCT06521710 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men with high-risk localized prostate cancer who have a baseline erectile function score of 17 or higher.
✕Probably not a fit
Patients with previous pelvic surgeries, radiotherapy, or those with pre-existing neurologic diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot trial evaluates the safety and effectiveness of a novel nerve grafting technique during robotic-assisted laparoscopic radical prostatectomy in patients with high-risk localized prostate cancer. A total of 10 patients will undergo surgery using the nerve restoring approach, which incorporates a genitofemoral nerve graft aimed at improving erectile function recovery post-surgery. Patients will be assessed for erectile function and pain using standardized questionnaires at multiple follow-up points over 18 months. The study aims to minimize complications while enhancing recovery outcomes for erectile function.
Why it matters
Potential benefit: If successful, this technique could significantly improve erectile function recovery in men undergoing prostate cancer surgery.
How similar studies have gone: While this approach is novel, similar nerve grafting techniques have shown promise in other surgical contexts, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Jewish General Hospital, CIUSSS Centre-Ouest de l'île de Montréal
Montreal, Quebec, Canada Recruiting -
Jewish General Hospital
Montreal, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Victor McPherson, MD — Jewish General Hospital
- Study coordinator: Victor McPherson, MD
- Email: victor.mcpherson@mcgill.ca
- Phone: 514-340-8222
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.