What is 4-aminopyridine studying for nerve injury after prostate surgery?

4-aminopyridine is being studied to see if it can speed recovery after nerve injury caused by prostate surgery. Researchers want to understand if this drug can help improve urinary control and erectile function following surgery. The study is led by John Elfar and focuses on men undergoing robotic prostate removal.

Who may be eligible for this nerve injury clinical trial?

Men aged 45 to 75 with organ-confined, non-metastatic prostate cancer planning robotic prostate surgery may be eligible. Participants need a certain level of erectile function and recent sexual activity. Other factors like PSA levels and no planned additional cancer treatments also apply. Please review eligibility criteria for more details.

Is there any cost to participate in this nerve injury clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any extra costs related to travel or accommodation.

Actively Recruiting

Phase 2

Phase 3

Age: 45Years - 75Years

MALE

ID03701581

4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy

Led by John Elfar · Updated on 2025-12-17

Participants Needed

Research Sites

74 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the potential effects of 4-aminopyridine 4-AP on recovery after peripheral nerve injuries caused by traction or crush. The study focuses on men with prostate cancer undergoing robot-assisted radical prostatectomy, as nerve injury during this surgery may lead to erectile dysfunction and urinary continence issues. This research aims to test whether 4-AP can speed up the often slow and unpredictable recovery process after such nerve injuries. Participants will receive either FDA-approved 10 mg 4-aminopyridine tablets or placebo tablets after surgery. The medication is taken orally, with a maximum of two tablets per 24 hours, and must be swallowed whole without breaking or crushing. The treatment period lasts for 60 days following surgery. The placebo is designed to look like the active drug, and participants will be reminded not to take other aminopyridine medications during the study. Throughout the study, participants will be monitored for changes in urinary incontinence and erectile function using standardized questionnaires every seven days for six months. They will also keep a daily drug diary for 90 days and complete sexual activity questionnaires regularly. The study includes follow-up for up to one year to assess recovery progress and safety. The total participation time involves regular assessments and monitoring after the surgery.

CONDITIONS

Brief Title

4-aminopyridine Treatment for Nerve Injury

Who Can Participate

Age: 45Years - 75Years

MALE

Eligibility Criteria

You may qualify if you...

Male patients with organ-confined, non-metastatic prostate cancer (stages cT1c-T2c) planning robotic-assisted laparoscopic bilateral nerve sparing radical prostatectomy
Prostate-Specific Antigen (PSA) levels less than 15 ng/ml within the last 12 months
Biopsy-proven prostate cancer with no expected need for postoperative adjuvant therapy
Age between 45 and 75 years
Abridged International Index of Erectile Function-Erectile Function (IIEF-5) score of 17 or higher at screening
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 erectile dysfunction treatments until 3 months after surgery
Able and willing to provide informed consent

You will not qualify if you...

Planned adjuvant therapy after surgery based on pathology or cancer stage (stage T3 or greater), positive lymph nodes, or positive surgical margins
Neo-adjuvant therapy before surgery
History of recurrent prostate cancer
History of seizures, multiple sclerosis, stroke, or other neurological disorders
History of non-organ confined or metastatic prostate cancer (stage T3 or greater)
Known allergy or hypersensitivity to 4-aminopyridine
History of penile surgery other than circumcision or endoscopic urethral stricture surgery
Renal impairment with calculated GFR less than 60 mL/min
Use of other aminopyridine medications for any indication

Research Team

Andrea Horne

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