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Recruiting NCT03701581

4-aminopyridine Treatment for Nerve Injury

Phase II / Phase III Interventional Nerve Injury Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 4-Aminopyridine, Placebo.
Who it may be relevant to
Registry conditions: Nerve Injury, Prostate Cancer. Basic parameters: 45 years — 75 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

To evaluate the role of 4-aminopyridine (4-AP) on the course of recovery after peripheral nerve traction and/or crush injury. This study aims to test the hypothesis that 4-aminopyridine speeds the often slow and unpredictable recovery after peripheral nerve traction and/or crush injuries.

Detailed description

To evaluate the role of 4-AP on the recovery of nerve function we will be giving patients with prostate cancer who are undergoing robot assisted radical prostatectomy (RP) either 4-AP or placebo in the perioperative period. This population of patients was selected as nerve crush injury during RP is thought to contribute to erectile dysfunction and urinary continence post operatively.

Interventions

  • Drug 4-Aminopyridine
    FDA-approved tablets.
  • Other Placebo
    Placebo will be tooled to look similar to the study drug.

Primary outcome measures

  • Michigan Incontinence Sympton Index (M-ISI) (change over time) [Time frame: Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).]
  • International Index of Erectile Function (IIEF) (change over time) [Time frame: Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).]
  • Placebo vs. Active Drug Questionnaire [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (2)
  • Drug Diary [Time frame: Daily for 90 days.]
  • Attempted Sexual Activity Questionnaire [Time frame: Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 2 centers
  • University of Arizona — Tucson
  • University of Rochester — Rochester

Publications

  • Ghazi A, Osinski TL, Feng C, Horne A, Elfar J. 4-Aminopyridine treatment for nerve injury resulting from radical retro-pubic prostatectomy: a single-center double-blind, randomized, placebo-controlled study. Trials. 2024 May 21;25(1):332. doi: 10.1186/s13063-024-08102-z. PMID 38773595

Identifiers

NCT: NCT03701581 · 00003869

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗