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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Prostate Disease

In brief

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.

Key facts

Study ID

NCT03658408

Run by

University of Rochester

People needed

0

Starts

2018-10-03

Expected to finish

2018-10-30

Last updated by the study team

2018-11-02

Who can join

Age: 45 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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