Clinical trial NCT06521710: Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assisted Radical Prostatectomy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Erectile Dysfunction
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

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

Primary outcomes:
measure: Adverse events measured by the Clavian-Dindo classification
timeFrame: Through study completion, an average of 18 months
Secondary outcomes:
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: Screening pre-NR-RALP procedure
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: 4-6 weeks post-NR-RALP procedure
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: 3 months post-NR-RALP procedure
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: 6 months post-NR-RALP procedure
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: 12 months post-NR-RALP procedure
measure: International Index of Erectile Function-5 (IIEF-5)
timeFrame: 18 months post-NR-RALP procedure
measure: Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: Screening pre-NR-RALP procedure
measure: Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 4-6 weeks post-NR-RALP procedure
measure: Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 3 months post-NR-RALP procedure
measure: Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 6 months post-NR-RALP procedure
measure: Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 12 months post-NR-RALP procedure
measure: Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 18 months post-NR-RALP procedure
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital, CIUSSS Centre-Ouest de l&#39;île de Montréal
state: Quebec
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Victor McPherson, MD
role: PRINCIPAL_INVESTIGATOR
References: