Nerve Injury, Prostate Cancer
Conditions
Keywords
prostatectomy, erectile dysfunction, prostate cancer, nerve injury, incontinence
Brief summary
To evaluate the role of 4-aminopyridine (4-AP) on the course of recovery after peripheral nerve traction and/or crush injury. This study aims to test the hypothesis that 4-aminopyridine speeds the often slow and unpredictable recovery after peripheral nerve traction and/or crush injuries.
Detailed description
To evaluate the role of 4-AP on the recovery of nerve function we will be giving patients with prostate cancer who are undergoing robot assisted radical prostatectomy (RP) either 4-AP or placebo in the perioperative period. This population of patients was selected as nerve crush injury during RP is thought to contribute to erectile dysfunction and urinary continence post operatively.
Interventions
DRUG4-Aminopyridine
FDA-approved tablets.
OTHERPlacebo
Placebo will be tooled to look similar to the study drug.
Sponsors
John Elfar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized placebo-controlled trial of 4AP vs placebo for nerve injury
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 15 ng/ml (within the last 12 months), 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 Abridged International Index of Erectile Function-Erectile Function (IIEF-5) score of greater than or equal to 17 at time of screening * Has experienced at least 6 months of regular sexual activity and sexual activity during the 12 weeks prior to prostate biopsy or surgery * Willingness to abstain from treatments for Erectile Dysfunction until 3 months after 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 * 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 4AP * 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 |
|---|---|---|
| Michigan Incontinence Sympton Index (M-ISI) (change over time) | Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times). | Incontinence measurement (change over time) |
| International Index of Erectile Function (IIEF) (change over time) | Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times). | Erectile function measurement tool. (change over time) |
| Placebo vs. Active Drug Questionnaire | through study completion, an average of 1 year | Specific questions regarding patient blinding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Drug Diary | Daily for 90 days. | Subjects will record the time each day that they take the study drug/ placebo. |
| Attempted Sexual Activity Questionnaire | Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times). | Sexual activity assessment |
Countries
United States
Contacts
Primary ContactAndrea Horne
Outcome results
None listed