4-aminopyridine Treatment for Nerve Injury

Launched by JOHN ELFAR · Oct 8, 2018

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called 4-aminopyridine (4-AP) can help improve recovery after certain types of nerve injuries, specifically in men undergoing surgery for prostate cancer. The hope is that 4-AP may speed up the healing process after these injuries, which can sometimes take a long time to recover from.

To participate in this study, you need to be a male between the ages of 45 and 75 who has been diagnosed with early-stage prostate cancer and is planning to have a specific type of surgery called a Robotic-Assisted Laparoscopic Bilateral Nerve Sparing Radical Prostatectomy. You should have normal prostate-specific antigen (PSA) levels and should not expect to need additional treatments after surgery. Participants will be asked to avoid treatments for erectile dysfunction for three months after the surgery. This trial is currently active but not recruiting new participants at this time.

Gender

MALE

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 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