Status:

RECRUITING

4-aminopyridine Treatment for Nerve Injury

Lead Sponsor:

John Elfar

Conditions:

Nerve Injury

Prostate Cancer

Eligibility:

MALE

45-75 years

Phase:

PHASE2

PHASE3

Brief 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 oft...

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 th...

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

Key Trial Info

Start Date :

June 5 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2028

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT03701581

Start Date

June 5 2021

End Date

December 1 2028

Last Update

December 17 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

University of Arizona

Tucson, Arizona, United States, 85724

2

University of Rochester

Rochester, New York, United States, 14602