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Procedure

Nerve Grafting for Prostate Cancer (NR-RALP Trial)

N/A
Recruiting
Led By Victor McPherson, MD
Research Sponsored by Sir Mortimer B. Davis - Jewish General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing standard of care robotic radical prostatectomy for high-risk localized prostate cancer as defined by Gleason grade ≥8, PSA ≥20, or >pT2 on preoperative MRI imaging
Be older than 18 years old
Must not have
Patients who are unable to complete questionnaires and have no companion to help complete them
Legally incapable patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months post-nr-ralp procedure
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new surgical technique called Nerve Restoring Robotically assisted laparoscopic radical prostatectomy (NR-RALP) on 10 patients undergoing robotic prostatectomy. The

Who is the study for?
This trial is for men with prostate cancer who are planning to undergo robotic surgery (RALP) and wish to preserve erectile function post-surgery. Specific eligibility details aren't provided, but typically participants must be in good health aside from their prostate condition.
What is being tested?
The study tests a new surgical technique called NR-RALP that uses a nerve graft during robotic prostatectomy. The goal is to improve erectile recovery after the procedure. It's a small pilot study involving only 10 patients.
What are the potential side effects?
While specific side effects are not listed, potential risks may include those associated with standard RALP such as urinary incontinence, changes in sexual function, and complications related to nerve grafting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having robotic surgery for high-risk prostate cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot fill out questionnaires on my own and have no one to help me.
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I am not legally able to make my own medical decisions.
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I have had surgery in my pelvic area before.
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I have had radiation therapy to my pelvic area before.
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I have had targeted treatment for prostate cancer.
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I was diagnosed with my condition before turning 18.
Select...
I am having surgery for another cancer at the same time.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months post-nr-ralp procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months post-nr-ralp procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events measured by the Clavian-Dindo classification
Secondary study objectives
International Index of Erectile Function-5 (IIEF-5)
Short Form McGill Pain Questionnaire (SF-MPQ)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NR-RALPExperimental Treatment1 Intervention
Nerve Grafting Technique in patients with High Grade Prostate Cancer Undergoing Robotic Assisted Radical Prostatectomy

Find a Location

Who is running the clinical trial?

Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
58 Previous Clinical Trials
21,206 Total Patients Enrolled
1 Trials studying Erectile Dysfunction
10 Patients Enrolled for Erectile Dysfunction
Victor McPherson, MDPrincipal InvestigatorJewish General Hospital
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Erectile Dysfunction
10 Patients Enrolled for Erectile Dysfunction
~7 spots leftby Sep 2027
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