RightFit
RecruitingPhase 2 / Phase 3

4-aminopyridine Treatment for Nerve Injury

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 75 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether 4-aminopyridine (4-AP) helps nerves heal faster after they are stretched or crushed. It is for men ages 45–75 with prostate cancer who plan to have robot-assisted surgery to remove the prostate while sparing nerves on both sides.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Male, age 45–75, with prostate cancer that has not spread outside the prostate (stages cT1c–T2c).
  • Planning robot-assisted surgery to remove the prostate while sparing nerves on both sides.
  • Cancer confirmed by a tissue sample, with a PSA blood test below 15 ng/ml within the past 12 months.
  • Not expected to need added treatment after surgery, such as radiation or hormone treatment.
  • Score of at least 17 on the IIEF-5 survey, which measures the ability to get and keep an erection.
  • At least 6 months of regular sexual activity, including activity during the 12 weeks before the prostate tissue sample or surgery.
  • Willing to avoid treatments for erection problems until 3 months after surgery.
  • Willing to take part and able to give informed consent.

Who can't join

  • Added treatment planned after surgery because cancer is stage T3 or higher, is in lymph nodes, or is found at the edge of removed tissue.
  • Cancer treatment before the planned prostate surgery.
  • Prostate cancer that has come back, or a history of cancer that spread outside the prostate (stage T3 or higher).
  • History of seizures, multiple sclerosis, stroke, or another diagnosed brain or nerve disorder.
  • Known allergy to 4-AP.
  • Past penis surgery, except circumcision or surgery using a scope to treat a narrowed urine tube.
  • Reduced kidney function, with a calculated filtering rate (GFR) below 60 mL/min.
  • Taking any other aminopyridine medicines for any reason.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

AZ

NY