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)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Arizona
Tucson, Arizona, United States, 85724
2
University of Rochester
Rochester, New York, United States, 14602