4-aminopyridine Treatment for Nerve Injury

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03701581
• Other study ID #: 57379
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: June 5, 2021
• Est. completion date: August 5, 2025

Study information

• Verified date: February 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: August 5, 2025
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Nerve Injury
• Prostate Cancer
• Prostatic Neoplasms
• Wounds and Injuries

Intervention

Drug:
• 4-Aminopyridine
FDA-approved tablets.

Other:
• Placebo
Placebo will be tooled to look similar to the study drug.

Locations

Country	Name	City	State
United States	University of Rochester Department of Urology	Rochester	New York
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
John Elfar	University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Michigan Incontinence Sympton Index (M-ISI) (change over time)	Incontinence measurement (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).
Primary	International Index of Erectile Function (IIEF) (change over time)	Erectile function measurement tool. (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).
Primary	University of Rochester Placebo vs. Active Drug Questionnaire	Specific questions regarding patient blinding	through study completion, an average of 1 year
Secondary	Drug Diary	Subjects will record the time each day that they take the study drug/ placebo.	Daily for 90 days.
Secondary	University of Rochester Attempted Sexual Activity Questionnaire	Sexual activity assessment	Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times).