Nerve grafting technique to help preserve erectile function after prostate surgery
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Sir Mortimer B. Davis - Jewish General Hospital Academic / other |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT06521710 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men with high-risk localized prostate cancer who have a baseline erectile function score of 17 or higher.
Not a fit: Patients with previous pelvic surgeries, radiotherapy, or those with pre-existing neurologic diseases may not benefit from this study.
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 performed: While this approach is novel, similar nerve grafting techniques have shown promise in other surgical contexts, suggesting potential for success.
Eligibility criteria
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 this trial is running
Montreal, Quebec and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.