Prostate Cancer Clinical Trial
Official title:
4-aminopyridine Treatment for Nerve Injury Resulting From Radical Retro-Pubic Prostatectomy
Verified date | February 2024 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 70 |
Est. completion date | August 5, 2025 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 45 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester Department of Urology | Rochester | New York |
United States | University of Rochester Medical Center | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
John Elfar | University of Arizona |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Michigan Incontinence Sympton Index (M-ISI) (change over time) | Incontinence measurement (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). | |
Primary | International Index of Erectile Function (IIEF) (change over time) | Erectile function measurement tool. (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). | |
Primary | University of Rochester Placebo vs. Active Drug Questionnaire | Specific questions regarding patient blinding | through study completion, an average of 1 year | |
Secondary | Drug Diary | Subjects will record the time each day that they take the study drug/ placebo. | Daily for 90 days. | |
Secondary | University of Rochester Attempted Sexual Activity Questionnaire | Sexual activity assessment | Pre-operative visit, and every seven days (starting after surgery, i.e., 7 days post-op) for 6 months (up to 25 times). |
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