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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Disease

Intervention / Treatment
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* Drug: 4-aminopyridine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4-aminopyridine<br>Participants with recent prostatectomies receiving 4-aminopyridine | Drug: 4-aminopyridine<br>* Oral tablet of 2.5 mg given 4 times a day<br>|
| Placebo Comparator: Placebo<br>Participants with recent prostatectomies receiving placebo | Drug: placebo<br>* 2.5 mg sugar pill given orally 4 times a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of participants with normal erectile dysfunction | 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time point at which the highest number of subjects reporting normal erectile dysfunction | 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. | baseline to month 12 | 
| percentage of participants with normal erectile dysfunction | 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. | week 3 | 
| percentage of participants with normal erectile dysfunction | 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. | week 4 | 
| percentage of participants with normal erectile dysfunction | 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. | week 6 | 
| percentage of participants with normal erectile dysfunction | 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. | week 8 | 
| percentage of participants with normal erectile dysfunction | 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. | week 10 | 
| percentage of participants with normal erectile dysfunction | 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. | week 12 | 
| percentage of participants with normal erectile dysfunction | 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. | week 14 | 
| percentage of participants with normal erectile dysfunction | 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. | week 16 | 
| percentage of participants with normal erectile dysfunction | 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. | week 18 | 
| percentage of participants with normal erectile dysfunction | 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. | week 20 | 
| percentage of participants with normal erectile dysfunction | 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. | week 22 | 
| percentage of participants with normal erectile dysfunction | 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. | week 24 | 
| percentage of participants with normal urinary continence | 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. | 2 months |