Nerve Grafting for Prostate Cancer

(NR-RALP Trial)

Recruiting at 1 trial location

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

Trial Summary

What is the purpose of this trial?

The investigator proposing a single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing Nerve Restoring (NR) Robotically assisted laparoscopic radical prostatectomy (RALP). During this study a total of 10 patients who are undergoing robotic prostatectomy will have their surgery performed utilizing a novel technique, NR-RALP, which incorporates a genitofemoral (GFN) nerve graft designed to try to improve the erectile function and recovery of men undergoing standard of care robotic prostatectomy while minimizing additional morbidity of the procedure

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 data supports the effectiveness of the treatment Intraoperative Somatic-Autonomic Nerve Grafting for prostate cancer?

Research on nerve-sparing techniques in prostate surgery, such as robot-assisted laparoscopic prostatectomy, shows that preserving nerves can improve outcomes like erectile function. Additionally, sural nerve grafting has been explored in similar surgeries, suggesting potential benefits in nerve restoration. ^{1 2 3 4 5}

Is nerve grafting during prostate surgery safe for humans?

Sural nerve grafting during prostate surgery has been reported using both open and minimally invasive methods, suggesting it is generally considered safe. The genitofemoral nerve is also noted for its low donor site morbidity (low risk of complications at the site where the nerve is taken), making it an appealing option for nerve grafting. ^{1 3 4 5 6}

How does the treatment Intraoperative Somatic-Autonomic Nerve Grafting differ from other treatments for prostate cancer?

Intraoperative Somatic-Autonomic Nerve Grafting is unique because it involves using nerve grafts to restore nerve function during prostate cancer surgery, aiming to preserve erectile function and improve quality of life, unlike standard procedures that may not focus on nerve restoration. ^{1 4 5 7 8}

Research Team

Victor McPherson, MD

Principal Investigator

Jewish General Hospital

Eligibility Criteria

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.

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

Patients with pre-existing neurologic disease

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

References

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

Sural nerve grafting in robotic laparoscopic radical prostatectomy: interim report. [2016]

2. Germany 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. [2018]

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. Brazil pubmed.ncbi.nlm.nih.gov

Techniques of nerve-sparing and potency outcomes following robot-assisted laparoscopic prostatectomy. [2022]

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

Results of unilateral genitofemoral nerve grafts with contralateral nerve sparing during radical prostatectomy. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Health-related quality of life evaluation in patients undergoing cavernous nerve reconstruction during radical prostatectomy. [2015]

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

Interposition of sural nerve restores function of cavernous nerves resected during radical prostatectomy. [2004]