Status:
RECRUITING
Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assisted Radical Prostatectomy
Lead Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
Conditions:
Prostate Cancer
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
NA
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 laparos...
Detailed Description
Patients will have baseline evaluation with International Index of Erectile Function-5 (IIEF-5) questionnaire and the Short Form McGill Pain Questionnaire (SF-MPQ)1, which will be re-evaluation at tim...
Eligibility Criteria
Inclusion
- Patients undergoing standard of care robotic radical prostatectomy for high-risk localized prostate cancer as defined by any of:
- Gleason grade ≥8
- PSA ≥20
- \>pT2 on preoperative MRI imaging
- Patients must have preoperative erectile function with a baseline IIEF score of ≥17
Exclusion
- Patients with previous pelvic surgery
- Patients with previous pelvic radiotherapy
- Patient with previous focal therapy for prostate cancer
- Patients aged \< 18 years at diagnosis
- Legally incapable patients
- Patients who are unable to complete questionnaires and have no companion to help complete them
- Patients undergoing a concomitant cancer surgery
- Patients with pre-existing neurologic disease
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06521710
Start Date
September 1 2024
End Date
December 1 2027
Last Update
September 19 2024
Active Locations (2)
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1
Jewish General Hospital, CIUSSS Centre-Ouest de l'île de Montréal
Montreal, Quebec, Canada, H3T 1E2
2
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2