Nerve Grafting for Prostate Cancer

(NR-RALP Trial)

Recruiting at 2 trial locations

Overseen By Victor McPherson, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

Disqualifiers: Previous pelvic surgery, radiotherapy, neurologic disease, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 day (surgery)

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new technique to help men with high-risk localized prostate cancer regain erectile function after surgery. The researchers use a special nerve graft, known as Intraoperative Somatic-Autonomic Nerve Grafting, during robotic prostate surgery to assess its impact on recovery and complication reduction. The trial seeks men undergoing prostate surgery who have good erectile function before surgery. The goal is to improve life quality after prostate surgery. Participants should not have had previous pelvic surgeries or treatments. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance post-surgical recovery for future patients.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this nerve grafting technique is safe for prostate cancer patients?

Research has shown that nerve grafting during surgery can help men regain erectile function. One study found that 71% of men regained this function after prostate surgery using this method. This suggests nerve grafting could be effective and relatively safe for those undergoing prostate procedures. Although specific safety details for this trial aren't provided, similar uses of nerve grafting have not shown major safety issues. Prospective participants should discuss potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the intraoperative somatic-autonomic nerve grafting technique because it offers a novel approach for preserving nerve function in patients undergoing robotic-assisted radical prostatectomy for high-grade prostate cancer. Unlike traditional treatments that often lead to nerve damage and subsequent side effects like erectile dysfunction and urinary incontinence, this technique aims to restore nerve pathways during surgery. By potentially minimizing these complications, the procedure could significantly improve quality of life for prostate cancer patients post-surgery.

What evidence suggests that this nerve grafting technique is effective for erectile recovery in prostate cancer patients?

Research has shown that using nerve grafts during prostate surgery can help restore nerve function. This trial studies a technique called Intraoperative Somatic-Autonomic Nerve Grafting, or NR-RALP. Earlier studies demonstrated that end-to-side nerve grafting helped about 71% of men regain erectile function after experiencing erectile dysfunction following prostate surgery. This method connects nerves to enhance their function post-operation. The goal is to improve recovery for men who have had prostate surgery, supporting erectile function while ensuring the procedure remains safe and effective. ^{1 3 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 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.

Inclusion Criteria

Patients must have preoperative erectile function with a baseline IIEF score of ≥17

I am having robotic surgery for high-risk prostate cancer.

Exclusion Criteria

I cannot fill out questionnaires on my own and have no one to help me.

Patients with pre-existing neurologic disease

I am not legally able to make my own medical decisions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo Nerve Restoring Robotically assisted laparoscopic radical prostatectomy (NR-RALP) with genitofemoral nerve grafting

1 day (surgery)

1 visit (in-person)

Post-operative Monitoring

Post-operative safety and erectile function are assessed at standard of care visits

18 months

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

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intraoperative Somatic-Autonomic Nerve Grafting

Trial Overview 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.

How Is the Trial Designed?

Group I: NR-RALP Experimental Treatment 1 Intervention

Nerve Grafting Technique in patients with High Grade Prostate Cancer Undergoing Robotic Assisted 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

Nerve-grafting surgery after prostatectomy significantly improved sexual function scores in patients who recovered potency compared to those who did not undergo nerve-sparing procedures, indicating its efficacy in enhancing health-related quality of life (HRQOL).

Despite the recovery of erectile function, many patients in the nerve-grafting group reported ongoing dissatisfaction with their sexual function, highlighting a disconnect between physical recovery and mental well-being related to sexual health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-related quality of life evaluation in patients undergoing cavernous nerve reconstruction during radical prostatectomy. Sugimoto, M., Tsunemori, H., Kakehi, Y.[2015]

In a study of 22 patients undergoing unilateral nerve-sparing radical prostatectomy, only 3 patients reported no erectile dysfunction after an average follow-up of 23 months, indicating limited success in preserving erectile function with this technique.

While the genitofemoral nerve grafting procedure had low donor site morbidity, 15 patients experienced severe erectile dysfunction post-surgery, and 8 reported mild chronic numbness, suggesting that the benefits of this approach are still uncertain and further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of unilateral genitofemoral nerve grafts with contralateral nerve sparing during radical prostatectomy. Joffe, R., Klotz, LH.[2015]

Sural nerve grafting during robot-assisted laparoscopic radical prostatectomy (RLRP) is technically feasible and safe, with no significant complications reported except for mild leg pain in one patient.

Despite the procedure being safe, there were no significant improvements in sexual or urinary function after 6 and 12 months compared to nerve-sparing techniques, indicating that further research with larger patient groups is needed to assess the true benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sural nerve grafting in robotic laparoscopic radical prostatectomy: interim report. Mikhail, AA., Song, DH., Zorn, KC., et al.[2016]

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]

Nerve sparing robot-assisted laparoscopic prostatectomy (RALP) is a widely accepted treatment for prostate cancer, with various techniques available, such as 'the veil of Aphrodite' and 'clipless cautery free technique', but no single technique has been proven superior.

Successful outcomes in RALP depend more on careful patient selection and meticulous surgical dissection rather than the specific technique used, emphasizing the importance of clinical judgment in achieving optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Techniques of nerve-sparing and potency outcomes following robot-assisted laparoscopic prostatectomy. Chauhan, S., Coelho, RF., Rocco, B., et al.[2022]

In a study involving 9 sexually active men who underwent radical prostatectomy with resection of both neurovascular bundles, the use of autologous sural nerve grafts showed promise in restoring erectile function, with patients reporting improved spontaneous erections within 4 to 5 months post-surgery.

By 14 months after the procedure, one patient achieved a rigid erection sufficient for penetration, indicating that nerve grafts may enhance recovery of erectile function after significant nerve damage during prostate cancer surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interposition of sural nerve restores function of cavernous nerves resected during radical prostatectomy. Kim, ED., Scardino, PT., Hampel, O., et al.[2004]

The study utilized data from 30 fresh and 25 fixed male cadavers, along with a video analysis of 205 surgeries, to enhance the understanding of pelvic autonomic neuroanatomy relevant to robotic prostatectomy.

The authors developed the Athermal Robotic Technique (ART) for nerve-sparing prostatectomy, identifying three critical zones for preserving nerve function, which may improve outcomes for patients undergoing this surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomy of autonomic nerve component in the male pelvis: the new concept from a perspective for robotic nerve sparing radical prostatectomy. Takenaka, A., Leung, RA., Fujisawa, M., et al.[2018]

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]

Citations

1. withpower.com withpower.com/trial/phase-prostatic-neoplasms-7-2024-5827d

Nerve Grafting for Prostate Cancer (NR-RALP Trial) Intraoperative Somatic-Autonomic Nerve Grafting is unique because it involves using nerve grafts to restore nerve function during prostate cancer surgery, ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2014804/

Robotically assisted laparoscopic radical prostatectomy CONCLUSION. RALP is a minimally invasive option for the treatment of prostate cancer that has proven short-term advantages over RRP with regard to blood loss, ...

5. europeanurology.com europeanurology.com/article/S0302-2838(19)30265-9/fulltext

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.

6. careacross.com careacross.com/clinical-trials/trial/NCT06521710

Nerve Grafting Technique to Preserve Erectile Function in ... Post-operative safety will be assessed by recording any clinically detected complications during their peri- and post-operative care. Criteria for eligibility:

7. 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 ... End-to-side somatic-to-autonomic nerve grafting to restore erectile function and improve quality of life after radical prostatectomy. Eur ...

8. 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.