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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03701581
Other study ID # 57379
Secondary ID
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


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).
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