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

NCT03658408•University of Rochester

Summary

The purpose of this study is to see if the study drug 4-aminopyridine (4-AP) can help speed up the recovery of peripheral nerve injury after prostatectomy. 4-AP is a potassium channel blocker used to improve walking in multiple sclerosis patients. Investigators will measure the effect that 4-AP may have on the recovery of sexual function and urinary incontinence after prostatectomy.

Eligibility

Age

45 - 75 years

Sex

MALE

Healthy Volunteers

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 10 ng/ml, 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 International Index of Erectile Function-Erectile Function (IIEF-5) score of greater than or equal to 17 at time of screening
•Is sexually active for at least 6 months with sexual activity within 6 weeks preceding prostate biopsy or 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.
•History of prior phosphodiesterase inhibitor use
•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 AMPYRA® or 4-aminopyridine
•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

Locations (1)

University of Rochester Medical Center

Rochester, New York, United States

Key Dates

Start Date

October 3, 2018

Primary Completion Date

October 30, 2018

Completion Date

October 30, 2018

Last Updated

November 2, 2018

Conditions

Prostate Disease

Interventions

4-aminopyridine

DRUG

placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 2, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

Exploring the Potential of Robotic Telesurgery in Remote Settings

TURP Inpatient With Underactive Bladder With BOO

High Resolution Diffusion Weighted Imaging in Prostate

Hemi-Gland Cryoablation for Prostate Cancer at UCLA

MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer

Focal US-guided Cryo-ablation Using DynaCAD / UroNAV Preplanning / Guidance of Intermediate Risk Prostate Cancer