RecruitingPhase 2Phase 3NCT03701581

4-aminopyridine Treatment for Nerve Injury

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

Sponsor

John Elfar

Enrollment

70 participants

Start Date

Jun 5, 2021

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Nerve Injury

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.

Eligibility

Sex: MALEMin Age: 45 YearsMax Age: 75 Years

Inclusion Criteria7

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 Criteria9

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