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

University of Rochester

Status and phase

Withdrawn

Phase 2

Conditions

Prostate Disease

Treatments

Drug: placebo

Drug: 4-aminopyridine

Study type

Interventional

Funder types

Other

Identifiers

NCT03658408

72666

Details and patient eligibility

About

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.

Sex

Male

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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