10 Participants Needed

Nerve Grafting for Erectile Dysfunction After Prostate Cancer Surgery

(PRP-NR Trial)

VM
OL
Overseen ByOleg Loutochin
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Must be taking: PDE5-I medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for erectile dysfunction after prostate cancer surgery?

Research suggests that nerve grafting techniques, like using sural nerve grafts, have shown modest success in restoring erectile function after prostate surgery. Additionally, platelet-rich plasma (PRP) has shown promise in nerve regeneration, which could help improve erectile function after nerve injury.12345

Is nerve grafting for erectile dysfunction after prostate cancer surgery safe?

Clinical studies have shown that using sural nerve grafts to repair damaged nerves during prostate cancer surgery is safe and feasible, with modest success in restoring erectile function.12456

How is the nerve grafting treatment for erectile dysfunction after prostate cancer surgery different from other treatments?

This treatment is unique because it involves using nerve grafts to restore erectile function by bridging damaged nerves, specifically using autologous sural nerve grafts, which is different from other treatments that may not focus on nerve reconstruction.23457

What is the purpose of this trial?

A single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing a somatic to autonomic nerve grafting procedure for restoration of erectile function in patients who have lost erectile function following radical prostatectomy for prostate cancer. During this study a total of 10 patients who have persistent erectile dysfunction for more than 18 months post prostatectomy will undergo a post radical prostatectomy nerve restoration procedure (PRP-NR).

Research Team

VM

Victor McPherson, MD

Principal Investigator

Jewish General Hospital

Eligibility Criteria

This trial is for men who've had prostate cancer surgery at least 18 months ago and are now experiencing persistent erectile dysfunction. It's a small study, aiming to include just 10 patients.

Inclusion Criteria

Patients must have had good pre-prostatectomy erectile function with a baseline IIEF score of ≥17 on self-reported assessment of historic function
I have had erectile dysfunction for over 18 months after prostate surgery, and medications don't help.

Exclusion Criteria

Patients with pre-existing neurologic disease
I have had surgery on both sides for a groin hernia.
I have had radiation therapy to my pelvic area before.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the post radical prostatectomy nerve restoration procedure (PRP-NR)

1 day
1 visit (in-person)

Post-operative Monitoring

Participants are monitored for safety and recovery outcomes with questionnaires and clinical assessments

24 months
Visits at 4 weeks, 3, 6, 12, 18, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Post radical prostatectomy nerve restoration procedure (PRP-NR)
Trial Overview The trial is testing a nerve grafting technique called PRP-NR that aims to restore erectile function in men who have lost it following prostate cancer surgery.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: PRP-NRExperimental Treatment1 Intervention
Post radical prostatectomy nerve restoration procedure

Post radical prostatectomy nerve restoration procedure (PRP-NR) is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Nerve grafting technique for erectile dysfunction for:
  • Erectile dysfunction post radical prostatectomy
🇪🇺
Approved in European Union as Post radical prostatectomy nerve restoration procedure for:
  • Erectile dysfunction post radical prostatectomy

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sir Mortimer B. Davis - Jewish General Hospital

Lead Sponsor

Trials
61
Recruited
25,800+

Findings from Research

In a study involving male Sprague-Dawley rats, platelet-rich plasma (PRP) injection into the corpus cavernosum after bilateral cavernous nerve injury significantly improved erectile function compared to a control group that received normal saline.
PRP treatment not only enhanced erectile function but also preserved the number of myelinated axons in the cavernous nerves and reduced cell apoptosis, indicating a neuroprotective effect that may aid in nerve regeneration.
The neuroprotective effect of platelet-rich plasma on erectile function in bilateral cavernous nerve injury rat model.Wu, CC., Wu, YN., Ho, HO., et al.[2012]
In a study involving 107 men undergoing unilateral nerve-sparing radical prostatectomy (RP), the addition of a sural nerve graft (SNG) did not significantly improve erectile function recovery at 2 years compared to RP alone, with potency rates of 48.5% for SNG and 34% for controls.
The trial was closed early due to futility, indicating that the expected benefits of SNG in enhancing erectile function post-surgery were not realized, and compliance with erectile dysfunction therapy was low, which may have affected outcomes.
Randomized phase II trial evaluation of erectile function after attempted unilateral cavernous nerve-sparing retropubic radical prostatectomy with versus without unilateral sural nerve grafting for clinically localized prostate cancer.Davis, JW., Chang, DW., Chevray, P., et al.[2023]
A new nerve graft technique has been developed to help restore erectile function after radical prostatectomy, particularly after the removal of neurovascular bundles.
Current literature shows limited scientific evidence supporting the effectiveness of this technique, indicating that more research is needed to validate its outcomes.
[Anatomic and experimental basis for nerve grafts after radical retropubic prostatectomy].Sebe, P., Peyromaure, M., Delmas, V.[2022]

References

The neuroprotective effect of platelet-rich plasma on erectile function in bilateral cavernous nerve injury rat model. [2012]
Randomized phase II trial evaluation of erectile function after attempted unilateral cavernous nerve-sparing retropubic radical prostatectomy with versus without unilateral sural nerve grafting for clinically localized prostate cancer. [2023]
[Anatomic and experimental basis for nerve grafts after radical retropubic prostatectomy]. [2022]
Strategies to promote recovery of cavernous nerve function after radical prostatectomy. [2007]
[Cavernous nerve reconstruction to restore erectile function following radical prostatectomy]. [2007]
The periprostatic autonomic nerves--bundle or layer? [2008]
Cavernous nerve reconstruction to preserve erectile function following non-nerve-sparing radical retropubic prostatectomy: a prospective study. [2015]
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