Nerve Grafting for Erectile Dysfunction After Prostate Cancer Surgery

(PRP-NR Trial)

Overseen By Oleg Loutochin

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Must be taking: PDE5-I medications

Disqualifiers: Pelvic radiotherapy, Neurologic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day

10 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

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. ^{2 3 4 5 7}

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

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.

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

Group I: PRP-NR Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Anatomic and experimental basis for nerve grafts after radical retropubic prostatectomy]. Sebe, P., Peyromaure, M., Delmas, V.[2022]

Penile autonomic nerve-sparing techniques during radical prostatectomy have improved recovery rates of erectile function, but many men still face challenges with delayed or incomplete recovery.

New strategies, such as cavernous nerve interposition grafting and neurotrophic treatments, show promise in enhancing nerve function and reducing erectile dysfunction after surgery, with early clinical successes indicating their potential effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to promote recovery of cavernous nerve function after radical prostatectomy. Burnett, AL.[2007]

Reconstruction of cavernous nerves during radical prostatectomy can help restore erectile function, which is often compromised due to nerve damage from the surgery.

Clinical studies using autologous sural nerve grafts have shown modest success, and laparoscopic sural nerve grafting has been demonstrated to be safe and feasible, indicating a potential pathway for improving post-operative outcomes in prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cavernous nerve reconstruction to restore erectile function following radical prostatectomy]. Song, LJ., Pan, LJ., Xu, YM.[2007]

A study analyzing 77 prostate specimens found that about two-thirds of the nerves are located in the posterolateral region, which is crucial for nerve-sparing radical prostatectomy (RP) procedures.

Surgeons should prioritize nerve preservation at the apex and mid-section of the anterior prostate, as nerve distribution varies significantly across different regions of the prostate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The periprostatic autonomic nerves--bundle or layer? Sievert, KD., Hennenlotter, J., Laible, I., et al.[2008]

In a study of 30 men undergoing non-nerve-sparing radical prostatectomy, autologous sural nerve grafting resulted in 60% of participants showing spontaneous erectile activity after surgery, indicating its efficacy in preserving erectile function post-operation.

The procedure did not lead to any disease or biochemical recurrences in patients with locally advanced prostate cancer, suggesting that it can effectively balance the preservation of erectile function with cancer control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cavernous nerve reconstruction to preserve erectile function following non-nerve-sparing radical retropubic prostatectomy: a prospective study. Chang, DW., Wood, CG., Kroll, SS., et al.[2015]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The neuroprotective effect of platelet-rich plasma on erectile function in bilateral cavernous nerve injury rat model. [2012]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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]

3. France pubmed.ncbi.nlm.nih.gov

[Anatomic and experimental basis for nerve grafts after radical retropubic prostatectomy]. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Strategies to promote recovery of cavernous nerve function after radical prostatectomy. [2007]

5. China pubmed.ncbi.nlm.nih.gov

[Cavernous nerve reconstruction to restore erectile function following radical prostatectomy]. [2007]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The periprostatic autonomic nerves--bundle or layer? [2008]

7. United States pubmed.ncbi.nlm.nih.gov

Cavernous nerve reconstruction to preserve erectile function following non-nerve-sparing radical retropubic prostatectomy: a prospective study. [2015]