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

NCT ID: NCT03658408

Last Updated: 2018-11-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-03
• Study Completion Date: 2018-10-30

Brief Summary

The purpose of this study is to see if the study drug 4-aminopyridine (4-AP) can help speed up the recovery of peripheral nerve injury after prostatectomy. 4-AP is a potassium channel blocker used to improve walking in multiple sclerosis patients. Investigators will measure the effect that 4-AP may have on the recovery of sexual function and urinary incontinence after prostatectomy.

Conditions

Prostate Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

4-aminopyridine

Participants with recent prostatectomies receiving 4-aminopyridine

Group Type: EXPERIMENTAL

4-aminopyridine

Intervention Type: DRUG

Oral tablet of 2.5 mg given 4 times a day

Placebo

Participants with recent prostatectomies receiving placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

2.5 mg sugar pill given orally 4 times a day

Interventions

4-aminopyridine

Oral tablet of 2.5 mg given 4 times a day

Intervention Type: DRUG

placebo

2.5 mg sugar pill given orally 4 times a day

Intervention Type: DRUG

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 10 ng/ml, 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 International Index of Erectile Function-Erectile Function (IIEF-5) score of greater than or equal to 17 at time of screening
• Is sexually active for at least 6 months with sexual activity within 6 weeks preceding prostate biopsy or 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.
• History of prior phosphodiesterase inhibitor use
• 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 AMPYRA® or 4-aminopyridine
• 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Ghazi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

72666

Identifier Type: -

Identifier Source: org_study_id