Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assisted Radical Prostatectomy

NCT06521710 | Recruiting DMC

• 1 other identifier: 2024-4129
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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

Conditions

Prostate Cancer; Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Adverse events measured by the Clavian-Dindo classification

  The primary outcome is specifically the safety of the operation measured by adverse events as defined by the Clavian-Dindo classification. The measurement varies from Grade I (Best possible outcome) to Grade V (Worst possible outcome). Grade I Deviation from normal p/o course. No pharmacological or surgical treatment, endoscopic or radiological interventions were required. Acceptable therapeutic drugs such as anti-emetics, antipyretics, analgesics, diuretics,electrolytes, physiotherapy. Wound infections, small abscess requiring incision at bedside. Grade II Normal course altered. Pharmacological management other than in Grade I. Blood transfusions and total parenteral nutrition are also included. Grade III Complications that require intervention of various degrees. Grade IV Complications threatening life of patients (including Central Nervous System complications), requiring Intensive Treatment Unit support. Grade V Death of a patient.

  Through study completion, an average of 18 months

Secondary Outcomes (12)

• International Index of Erectile Function-5 (IIEF-5)

  Screening pre-NR-RALP procedure

• International Index of Erectile Function-5 (IIEF-5)

  4-6 weeks post-NR-RALP procedure

• International Index of Erectile Function-5 (IIEF-5)

  3 months post-NR-RALP procedure

• International Index of Erectile Function-5 (IIEF-5)

  6 months post-NR-RALP procedure

• International Index of Erectile Function-5 (IIEF-5)

  12 months post-NR-RALP procedure

Study Arms (1)

NR-RALP

EXPERIMENTAL

Nerve Grafting Technique in patients with High Grade Prostate Cancer Undergoing Robotic Assisted Radical Prostatectomy

Procedure: Intraoperative Somatic-Autonomic Nerve Grafting

Interventions

Intraoperative Somatic-Autonomic Nerve Grafting PROCEDURE

A one-sided graft using a genitofemoral (GFN) nerve graft between one obturator nerve and the corpora cavernosa

NR-RALP

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (2)

Jewish General Hospital, CIUSSS Centre-Ouest de l&#39;île de Montréal

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Victor McPherson, MD

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor McPherson, MD

CONTACT

514-340-8222; victor.mcpherson@mcgill.ca

Oleg Loutochin

CONTACT

514-340-8222; oloutochin@jgh.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, FRCSC, Assistant Professor Division of Urology

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 26, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CA (2)