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Trial Title:
Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assisted Radical Prostatectomy
NCT ID:
NCT06521710
Condition:
Prostate Cancer
Erectile Dysfunction
Conditions: Official terms:
Prostatic Neoplasms
Erectile Dysfunction
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Intraoperative Somatic-Autonomic Nerve Grafting
Description:
A one-sided graft using a genitofemoral (GFN) nerve graft between one obturator nerve and
the corpora cavernosa
Arm group label:
NR-RALP
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
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 time of their standard of care post-operative visits at 4 weeks, 3-,
6-, 12- and 18-months. Post-operative safety will be assessed by recording any clinically
detected complications during their peri- and post-operative care.
Criteria for eligibility:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jewish General Hospital, CIUSSS Centre-Ouest de l'île de Montréal
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Victor McPherson, MD
Phone:
514-340-8222
Phone ext:
21627
Email:
victor.mcpherson@mcgill.ca
Facility:
Name:
Jewish General Hospital
Address:
City:
Montréal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Victor McPherson, MD
Phone:
514-340-8222
Phone ext:
24904
Email:
victor.mcpherson@gmail.com
Contact backup:
Last name:
Oleg Loutochin
Phone:
514-340-8222
Phone ext:
21627
Email:
oloutochin@jgh.mcgill.ca
Start date:
September 2024
Completion date:
December 2027
Lead sponsor:
Agency:
Sir Mortimer B. Davis - Jewish General Hospital
Agency class:
Other
Source:
Sir Mortimer B. Davis - Jewish General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06521710
