4-aminopyridine Treatment for Nerve Injury



Status:Not yet recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:45 - 70
Updated:2/17/2019
Start Date:July 1, 2019
End Date:December 1, 2022
Contact:Elizabeth Galgocy
Email:egalgocy@pennstatehealth.psu.edu
Phone:(717) 531-8521

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


Inclusion Criteria:

- Male patients with organ-confined, non-metastatic prostate cancer (stages CT1c-T2c)

- Prostate-specific antigen (PSA) levels less than 10 ng/ml; a Gleason score less than
or equal to 8 (prostate biopsy-proven)

- Ages 45-70

- Undergoing Robotic-assisted Laparoscopic Nerve sparing radical prostatectomy (NSRP)
for biopsy-proven prostate cancer

- An International Index of Erectile Function- Erectile Function greater than 18 at time
of screening (after cancer diagnosis, and greater than 6 weeks before NSRP)

- Able to provide informed consent

Exclusion Criteria:

- Adjuvant therapy after NSRP based on specimen pathology and stage of prostate cancer
(stage T3 or greater)

- 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 (stages T3 or greater)

- History of hypersensitivity to AMPYRA or 4-aminopyridine

- Preoperative history of urinary incontinence and/or use of urinary incontinence pads

- Patients with history of penile surgery

- Renal impairment based on calculated GFR (GFR<80 mL/min)
We found this trial at
1
site
University of Rochester, Department of Urology
Rochester, New York 14642
Principal Investigator: John Elfar, MD
Phone: 585-275-0126
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mi
from
Rochester, NY
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