Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assisted Radical Prostatectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraoperative Somatic-Autonomic Nerve Grafting.
- Who it may be relevant to
- Registry conditions: Prostate Cancer, Erectile Dysfunction. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Procedure Intraoperative Somatic-Autonomic Nerve Grafting
A one-sided graft using a genitofemoral (GFN) nerve graft between one obturator nerve and the corpora cavernosa
Primary outcome measures
- Adverse events measured by the Clavian-Dindo classification [Time frame: Through study completion, an average of 18 months]
Secondary outcome measures (12)
- International Index of Erectile Function-5 (IIEF-5) [Time frame: Screening pre-NR-RALP procedure]
- International Index of Erectile Function-5 (IIEF-5) [Time frame: 4-6 weeks post-NR-RALP procedure]
- International Index of Erectile Function-5 (IIEF-5) [Time frame: 3 months post-NR-RALP procedure]
- International Index of Erectile Function-5 (IIEF-5) [Time frame: 6 months post-NR-RALP procedure]
- International Index of Erectile Function-5 (IIEF-5) [Time frame: 12 months post-NR-RALP procedure]
- International Index of Erectile Function-5 (IIEF-5) [Time frame: 18 months post-NR-RALP procedure]
- Short Form McGill Pain Questionnaire (SF-MPQ) [Time frame: Screening pre-NR-RALP procedure]
- Short Form McGill Pain Questionnaire (SF-MPQ) [Time frame: 4-6 weeks post-NR-RALP procedure]
- Short Form McGill Pain Questionnaire (SF-MPQ) [Time frame: 3 months post-NR-RALP procedure]
- Short Form McGill Pain Questionnaire (SF-MPQ) [Time frame: 6 months post-NR-RALP procedure]
- Short Form McGill Pain Questionnaire (SF-MPQ) [Time frame: 12 months post-NR-RALP procedure]
- Short Form McGill Pain Questionnaire (SF-MPQ) [Time frame: 18 months post-NR-RALP procedure]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- Jewish General Hospital, CIUSSS Centre-Ouest de l'île de Montréal — Montreal
- Jewish General Hospital — Montreal
Identifiers
NCT: NCT06521710 · 2024-4129