Prostate Disease
Conditions
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.
Interventions
DRUG4-aminopyridine
Oral tablet of 2.5 mg given 4 times a day
DRUGplacebo
2.5 mg sugar pill given orally 4 times a day
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of participants with normal erectile dysfunction | 2 months | Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the time point at which the highest number of subjects reporting normal erectile dysfunction | baseline to month 12 | Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. |
| percentage of participants with normal erectile dysfunction | week 3 | Erectile dysfunction will be assessed using the International Index of Erectile Function. Normal will be defined as a return to baseline. The index ranges from 0-75 with higher scores indicating better outcome. A score of 0-5 is awarded to each of the 15 questions that examine the 4 main domains of male sexual function: erectile function, orgasmic function, sexual desire and intercourse satisfaction. |
| percentage of participants with normal urinary continence | 2 months | Incontinence will be assessed using the Michigan Incontinence Symptom Index. The Michigan Incontinence Symptom Index ranges from 0-40 with higher scores indicating more problems with urinary incontinence. |
Countries
United States
Outcome results
None listed