Nerve Grafting for Erectile Dysfunction After Prostate Cancer Surgery
(PRP-NR Trial)
Recruiting in Palo Alto (17 mi)
Overseen byVictor McPherson, MD
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Must be taking: PDE5-I medications
Disqualifiers: Pelvic radiotherapy, Neurologic disease, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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).
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.
12345Is 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.
12456How 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.
23457Eligibility 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.
+3 more
Trial 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
Participant Groups
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.
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, Australia 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
🇦🇺 Approved in Australia as Somatic-to-autonomic nerve grafting for:
- Erectile dysfunction post radical prostatectomy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Jewish General HospitalMontréal, Canada
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Who Is Running the Clinical Trial?
Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
References
The neuroprotective effect of platelet-rich plasma on erectile function in bilateral cavernous nerve injury rat model. [2012]Neurogenic erectile dysfunction resulting from cavernous nerve (CN) injury is a major complication caused by radical prostatectomy. The use of platelet-rich plasma (PRP) on the nerve-injured site has shown promising results for the nerve regeneration. However, the effects of PRP injection in corpus cavernosum after bilateral CN injury have never been investigated.
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]Nonrandomized studies of unilateral nerve-sparing (UNS) radical prostatectomy (RP) have reported improved recovery of erectile function if the sacrificed cavernous nerve is reconstructed with a sural nerve graft (SNG).
[Anatomic and experimental basis for nerve grafts after radical retropubic prostatectomy]. [2022]A nerve graft technique has been developed to restore erectile function after radical prostatectomy, following bilateral resection of the neurovascular bundles. The objective of this review of the literature is to describe this new surgical technique and analyse its anatomical and experimental bases. According to the current data of the literature, there is little scientific evidence to support the preliminary results.
Strategies to promote recovery of cavernous nerve function after radical prostatectomy. [2007]While the application of penile autonomic nerve-sparing techniques during radical prostatectomy for clinically localized prostate cancer has improved erection recovery rates after surgery, many men still experience delayed or incomplete recovery of erectile function. In recognition of neuropathy as a likely basis for erectile dysfunction after radical prostatectomy, investigators have begun exploring new strategies to promote the functional recovery of nerves responsible for penile erection in the course of this management. Primary efforts continue for preserving the integrity of the penile nerves, while the next frontier in clinical management has encompassed strategies directed toward maximally restoring their function. Such strategies include cavernous nerve interposition grafting and neurotrophic treatments that meet nerve reconstructive and nerve regenerative objectives, respectively. Early successes with both innovations preclinically and clinically suggest their feasibility and potential roles to reduce the incidence of erectile dysfunction after radical prostatectomy. The purpose of this report is to review strategies under development to promote post-prostatectomy erectile function, particularly with respect to preserving penile innervation involved in this function.
[Cavernous nerve reconstruction to restore erectile function following radical prostatectomy]. [2007]Recent years have seen an increasing incidence of prostate cancer (PCa) and a more frequent occurrence of the disease in younger men. Damage to cavernous nerves caused by radical prostatectomy is the main reason for post-operative erectile dysfunction. So reconstruction of cavernous nerves at the time of radical prostatectomy may restore the patient's erectile function. At present, clinical studies of using autologous sural nerve grafts to bridge transected cavernous nerves have achieved modest success, and laparoscopic sural nerve grafting during radical prostatectomy has also been proved safe and feasible. Besides, various grafts have been used to reconstruct cavernous nerves in animal models, among which biodegradable conduits containing growth-promoting factors or cells are a promising option for the repair of damaged cavernous nerves.
The periprostatic autonomic nerves--bundle or layer? [2008]The functional outcome of a nerve-sparing radical prostatectomy (RP) depends on the knowledge of autonomic nerve distribution in correlation to the prostate.
Cavernous nerve reconstruction to preserve erectile function following non-nerve-sparing radical retropubic prostatectomy: a prospective study. [2015]Erectile dysfunction following radical prostatectomy for treatment of clinically localized prostate cancer remains a problem that deters many men from seeking surgical treatment. Sparing the cavernous nerves has been popularized as a method of preserving potency, but men with locally advanced disease may be at increased risk for positive margins with this technique. In this study, sural nerve grafting of the cavernous nerve bundles, to preserve postoperative potency while potentially maximizing cancer control, was examined. Thirty men were enrolled in this prospective phase I study and underwent non-nerve-sparing radical prostatectomy performed by one of two protocol surgeons. Preoperative erectile function was assessed both objectively, using a RigiScan (Timm Medical Technologies, Inc., Eden Prairie, Minn.), and subjectively. The cavernous nerves were identified and resected during the operation with the use of an intraoperative mapping device (CaverMap; Alliant Medical Technologies, Norwood, Mass.). Bilateral autologous sural nerve grafting to the cavernous nerve stumps was performed by one of two protocol plastic surgeons. Postoperative erectile dysfunction therapy, using intracorporeal injection, a vacuum pump, and/or oral sildenafil therapy, was instituted 6 weeks after the operation. Spontaneous erectile activity was subjectively and objectively measured every 3 months after the operation. Follow-up periods ranged from 13 to 33 months (mean, 23 months). Overall, 18 of 30 patients (60 percent) demonstrated both objective and subjective evidence of spontaneous erectile activity. Of those 18 men, 13 (72 percent) were able to have intercourse (seven unassisted and six with the aid of sildenafil). No disease or biochemical recurrences have been noted in this group of patients with locally advanced disease. In conclusion, autologous sural nerve grafting after non-nerve-sparing radical prostatectomy is an effective means of preserving spontaneous erectile activity after the operation while maximizing cancer control potential.