Nerve Grafting for Erectile Dysfunction After Prostate Cancer Surgery

(PRP-NR Trial)

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new procedure to help men regain erectile function after prostate cancer surgery. It examines a nerve grafting technique aimed at restoring erectile ability in those who have experienced erectile dysfunction for more than 18 months post-surgery. Men who had normal erectile function before surgery but now cannot have intercourse, even with medication, might be suitable candidates for this trial. Participants will undergo a new nerve restoration procedure, known as the Post Radical Prostatectomy Nerve Restoration procedure (PRP-NR), to determine its effectiveness in improving their condition. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to significant advancements in treating post-surgical erectile dysfunction.

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 prior data suggests that this nerve grafting procedure is safe for erectile dysfunction after prostate cancer surgery?

Research has shown that nerve grafting procedures, like the one being tested, have promising safety results. In one study, 71% of patients who underwent a similar nerve graft experienced improvement in erectile function, suggesting that many men handle the procedure well. Another study found that 94% of patients were satisfied with their outcomes, indicating a good safety record.

While these results are encouraging, it is important to remember that this procedure remains under study. The data so far indicate it is generally well-tolerated, with a high success rate in restoring function. However, like any medical procedure, risks and side effects can occur. Participants should discuss potential risks with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for erectile dysfunction after prostate cancer surgery, which often involve medications like PDE5 inhibitors or devices such as vacuum erection devices, the post radical prostatectomy nerve restoration procedure (PRP-NR) targets nerve regeneration directly. Researchers are excited about this technique because it aims to restore the natural nerve pathways that are usually damaged during prostate surgery, potentially leading to more permanent solutions. This method focuses on actually repairing the underlying issue rather than just treating the symptoms, which could improve long-term outcomes for patients.

What evidence suggests that this nerve grafting technique is effective for erectile dysfunction?

Research has shown that end-to-side nerve grafting, used in the post radical prostatectomy nerve restoration procedure (PRP-NR), yields promising results. Specifically, studies found that this nerve grafting helped 71% of men regain erectile function after prostate surgery. This suggests the procedure can be effective for those who have lost function after surgery. Although some sources indicate the technique is not yet fully proven, data from successful cases supports its potential. ^{3 4 6 7 8}

Who Is on the Research Team?

Victor McPherson, MD

Principal Investigator

Jewish General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30955973/

End-to-side Somatic-to-autonomic Nerve Grafting ... End-to-side nerve grafting restored erectile function in 71% of men with ED following RP, supporting previous findings.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0302283819302659

End-to-side Somatic-to-autonomic Nerve Grafting to ... End-to-side nerve grafting restored erectile function in 71% of men with ED following RP, supporting previous findings.

3. journals.lww.com journals.lww.com/prsgo/fulltext/2025/10000/nerve_repair_for_erectile_dysfunction_after.18.aspx

Nerve Repair for Erectile Dysfunction After Radical... Bilateral sural nerve grafting demonstrated the highest recovery rates, with up to 71% of patients regaining erectile function sufficient for ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07188064?cond=prostate+cancer

A Study Looking at a New Nerve Surgery to Help Men ... During this study a total of 100 patients who have persistent erectile dysfunction for more than 18 months post prostatectomy will undergo a ...

5. uhcprovider.com uhcprovider.com/content/dam/provider/docs/public/policies/medicaid-comm-plan/nc/nerve-graft-restore-erectile-function-during-radical-prostatectomy-nc-cs.pdf

Nerve Graft to Restore Erectile Function During Radical ... Autologous (e.g., sural) or allogenic nerve grafts to restore erectile function during or after radical prostatectomy are unproven and not ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07188064

A Study Looking at a New Nerve Surgery to Help Men ... A single arm prospective pilot trial evaluating the 1-year erectile recovery outcomes and the safety of patients undergoing a somatic to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12490649/

Nerve Repair for Erectile Dysfunction After Radical ... Bilateral sural nerve grafting demonstrated the highest recovery rates, with up to 71% of patients regaining erectile function sufficient for ...

8. careacross.com careacross.com/clinical-trials/trial/NCT06458855

Nerve Grafting Technique to Restore Erectile Function Post ... Summary: A single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing a somatic to autonomic ...