NCT06521710Recruiting
Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assisted Radical Prostatectomy
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
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 21 Jul 2024
- Start date
- Sept 2024
- Primary completion date
- Sept 2027
- Lead sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT06521710
What you commit to
- Study type: Interventional
- Planned participants: 10
- From Sept 2024 to the primary completion date, Sept 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with previous pelvic surgery
- Patients with previous pelvic radiotherapy
- Patient with previous focal therapy for prostate cancer
- Patients undergoing a concomitant cancer surgery
Other illness
- Patients with pre-existing neurologic disease
Age
- Patients aged \< 18 years at diagnosis
Other
- Legally incapable patients
- Patients who are unable to complete questionnaires and have no companion to help complete them
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jewish General Hospital, CIUSSS Centre-Ouest de l'île de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.