Using 4-aminopyridine to improve recovery from nerve injury after prostate surgery
4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy
This study is testing if a medication called 4-aminopyridine can help men recover better from nerve injuries after prostate surgery, possibly reducing issues like erectile dysfunction and urinary incontinence.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | Male |
| Sponsor | University of Arizona Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Tucson, Arizona and 1 other locations) |
| Trial ID | NCT03701581 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 4-aminopyridine (4-AP) in enhancing recovery after peripheral nerve injuries that may occur during robotic-assisted radical prostatectomy in men with prostate cancer. Participants will receive either 4-AP or a placebo during the perioperative period to determine if the treatment can accelerate nerve function recovery, potentially reducing postoperative erectile dysfunction and urinary incontinence. The study aims to provide insights into the role of 4-AP in nerve repair and recovery.
Who should consider this trial
Good fit: Ideal candidates are male patients aged 45-75 with organ-confined, non-metastatic prostate cancer planning to undergo nerve-sparing prostate surgery.
Not a fit: Patients who require adjuvant therapy after surgery or have severe erectile dysfunction prior to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients undergoing prostate surgery, reducing the incidence of erectile dysfunction and urinary incontinence.
How similar studies have performed: Other studies have explored nerve recovery treatments, but the specific use of 4-aminopyridine in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Male patients with organ-confined, non-metastatic prostate cancer (stages cT1c-T2c), planning to undergo Robotic-Assisted Laparoscopic Bilateral Nerve Sparing Radical Prostatectomy (NSRP) * Prostate-Specific Antigen (PSA) levels less than 15 ng/ml (within the last 12 months), with biopsy-proven prostate cancer, for whom postoperative adjuvant therapy (e.g. radiation or androgen deprivation therapy) is not expected to be needed * Ages 45-75 * An Abridged International Index of Erectile Function-Erectile Function (IIEF-5) score of greater than or equal to 17 at time of screening * Has experienced at least 6 months of regular sexual activity and sexual activity during the 12 weeks prior to prostate biopsy or surgery * Willingness to abstain from treatments for Erectile Dysfunction until 3 months after surgery * Willingness to participate and able to provide informed consent Exclusion Criteria * Planned adjuvant therapy after NSRP based on specimen pathology and stage of prostate cancer (stage T3 or greater), positive lymph nodes or positive surgical margins * Neo-adjuvant therapy prior to NSRP * History of recurrent prostate cancer * History of seizures, multiple sclerosis, stroke or any other diagnosed neurological disorder * History of non-organ confined or metastatic prostate cancer (clinical Stages T3 or greater) * History of known hypersensitivity to 4AP * Patients with history of penile surgery other than circumcision or endoscopic urethral stricture surgery * Renal impairment based on calculated GFR (GFR\<60 mL/min) * Use of any other aminopyridine medications for any other indication
Where this trial is running
Tucson, Arizona and 1 other locations
- University of Arizona — Tucson, Arizona, United States (Recruiting)
- University of Rochester — Rochester, New York, United States (Terminated)
Study contacts
- Principal investigator: Rashid Sayyid, MD — University of Arizona
- Study coordinator: Andrea Horne
- Email: ahh@arizona.edu
- Phone: 520-626-6456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.