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

• Status: Withdrawn
• Trial end date: 2018-10-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Treatments: 4-Aminopyridine

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 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