Nerve Grafting for Erectile Dysfunction After Prostate Cancer Surgery (PRP-NR Trial)
Palo Alto (17 mi)Overseen byVictor McPherson, MD
Age: 18+
Sex: Male
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
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).
Is the treatment PRP-NR a promising treatment for erectile dysfunction after prostate cancer surgery?Yes, PRP-NR, which involves nerve grafting, shows promise in helping men regain erectile function after prostate cancer surgery. Studies have shown that this treatment can help restore nerve function, leading to improved chances of spontaneous erections and the ability to have intercourse.12346
What safety data exists for nerve grafting in erectile dysfunction after prostate surgery?Clinical studies have shown that using autologous sural nerve grafts to bridge transected cavernous nerves during radical prostatectomy is safe and feasible. Laparoscopic sural nerve grafting has also been proven safe. Additionally, early successes in both preclinical and clinical settings suggest the feasibility and potential of nerve grafting techniques to reduce erectile dysfunction after prostate surgery.34567
What data supports the idea that Nerve Grafting for Erectile Dysfunction After Prostate Cancer Surgery is an effective treatment?The available research shows that nerve grafting techniques, such as using sural nerve grafts, have shown some success in restoring erectile function after prostate cancer surgery. Studies indicate that these techniques can help improve the recovery of erectile function by reconstructing damaged nerves. For example, one study found that using a sural nerve graft during surgery improved erectile function recovery compared to not using the graft. Additionally, other research highlights the potential of nerve grafting to reduce the incidence of erectile dysfunction after surgery, suggesting it is a promising option for patients.13467
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves patients who cannot achieve intercourse with the aid of PDE5-I medications, it might be assumed that you can continue taking them if they are not effective for you.
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.Exclusion Criteria
I have had surgery on both sides for a groin hernia.
I have had radiation therapy to my pelvic area before.
I was diagnosed with my condition before turning 18.
I am not legally able to make my own medical decisions.
I cannot fill out questionnaires on my own and have no one to help me.
Treatment Details
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
[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.
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.
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.
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).
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.