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4-aminopyridine Treatment for Nerve Injury after Prostate Cancer Surgery

This study is testing whether 4-aminopyridine, an FDA-approved medication, can help men recover faster from nerve injury that can happen during prostate cancer surgery. This nerve injury can affect urinary control and erectile function. You would receive either 4-aminopyridine or a placebo (an inactive pill that looks the same). Researchers will measure changes in your urinary control and erectile function over time to see if 4-aminopyridine makes a difference. The study is for men aged 45 to 75 with specific types of prostate cancer who are having robotic-assisted surgery. The current status of this study is unclear, and it plans to enroll 70 participants.

Study design
This interventional study plans to enroll 70 male participants. It compares 4-aminopyridine to a placebo.
What's involved
You would take either 4-aminopyridine or a placebo. Your urinary control and erectile function would be measured at a pre-operative visit and weekly for 6 months after surgery, up to 25 times.
Compensation
Not stated in the trial record.
Follow-up
Your urinary control and erectile function will be measured for 6 months after surgery. You will also complete a questionnaire through study completion, which averages 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03701581

4-aminopyridine Treatment for Nerve Injury

Recruiting
PHASE2Ages 45–75InterventionalTreatment
John Elfar
~70 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:4-AminopyridinePlacebo

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Michigan Incontinence Sympton Index (M-ISI) (change over time)
Measured over Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).
+2 more outcomes measured

Conditions

Nerve Injury
Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

2 sites across 2 states
Arizona1
New York1

Study leadership

  • Rashid Sayyid, MD · PRINCIPAL_INVESTIGATOR · University of Arizona
  • John Elfar, MD · STUDY_CHAIR · University of Arizona

Who to contact

Andrea Horne
[email protected]
520-626-6456
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Michigan Incontinence Sympton Index (M-ISI) (change over time)Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).

    Incontinence measurement (change over time)

  • International Index of Erectile Function (IIEF) (change over time)Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).

    Erectile function measurement tool. (change over time)

  • Placebo vs. Active Drug Questionnairethrough study completion, an average of 1 year

    Specific questions regarding patient blinding