Clinical trial NCT03658408: 4-aminopyridine Treatment for Nerve Injury From Radical Retro-Pubic Prostatectomy
Official title: 4-aminopyridine Treatment for Nerve Injury From Radical Retro-Pubic Prostatectomy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Prostate Disease
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 0
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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 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

Primary outcomes:
measure: percentage of participants with normal erectile dysfunction
timeFrame: 2 months
Secondary outcomes:
measure: the time point at which the highest number of subjects reporting normal erectile dysfunction
timeFrame: baseline to month 12
measure: percentage of participants with normal erectile dysfunction
timeFrame: week 3
measure: percentage of participants with normal erectile dysfunction
timeFrame: week 4
measure: percentage of participants with normal erectile dysfunction
timeFrame: week 6
measure: percentage of participants with normal erectile dysfunction
timeFrame: week 8
measure: percentage of participants with normal erectile dysfunction
timeFrame: week 10
measure: percentage of participants with normal erectile dysfunction
timeFrame: week 12
measure: percentage of participants with normal erectile dysfunction
timeFrame: week 14
measure: percentage of participants with normal erectile dysfunction
timeFrame: week 16
measure: percentage of participants with normal erectile dysfunction
timeFrame: week 18
measure: percentage of participants with normal erectile dysfunction
timeFrame: week 20
measure: percentage of participants with normal erectile dysfunction
timeFrame: week 22
measure: percentage of participants with normal erectile dysfunction
timeFrame: week 24
measure: percentage of participants with normal urinary continence
timeFrame: 2 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: