Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
45 – 75
Sex
Male
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
John Elfar · Other
Who this trial is looking for
This trial is looking for men with early-stage prostate cancer who are about to have surgery. Participants will be given a medication called 4-aminopyridine to see if it helps with recovery from nerve injuries after surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am a man with non-metastatic prostate cancer.
I am planning to have a specific type of prostate surgery.
My PSA levels are less than 15 ng/ml.
I am between 45 and 75 years old.
I have had regular sexual activity for at least 6 months.
I agree to wait 3 months after surgery before starting any erectile dysfunction treatments.
I can provide informed consent.
You may not be able to join if
I am expecting to need additional treatments after surgery.
I have had treatment for prostate cancer before my surgery.
I have a history of seizures or other neurological disorders.
I have advanced prostate cancer.
I have a known allergy to 4-aminopyridine.
I have had penile surgery that is not circumcision.
I have kidney problems.
I am taking other aminopyridine medications.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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), w…
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
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