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New treatment option for Prostate Cancer
Official title Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assisted Radical Prostatectomy
ClinicalTrials.gov ID: NCT06521710
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join 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 likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.