This phase IV trial studies how well 4AP works in treating nerve injury from retropubic prostatectomy in patients with prostate cancer that has not spread to other parts of the body (localized). Retropubic prostatectomy is a surgery used to remove the prostate through an incision made in the wall of the abdomen. A known risk of this surgery is nerve injury, which may result in issues with sexual function or the inability to hold urine in the bladder. 4AP is an approved treatment for multiple sclerosis. Multiple sclerosis is a disorder that affects the myelin sheaths that cover the neurons in the nervous system. Nerve injury resulting from retropubic prostatectomy often affects the myelin sheaths. 4AP is a potassium channel blocker that enhances the neuronal transmission in affected myelin sheaths. 4AP may be an effective way to treat nerve injury from retropubic prostatectomy in patients with localized prostate cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03701581.
Locations matching your search criteria
United States
Arizona
Tucson
Banner University Medical Center - TucsonStatus: Active
Contact: Rashid Sayyid
Phone: 520-626-6393
PRIMARY OBJECTIVE:
I. To evaluate the role of dalfampridine (4-aminopyridine [4AP]) on the course of recovery after peripheral nerve injury specific to that suffered in the setting of prostatectomy surgery.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Starting the day after surgery, patients receive 4AP orally (PO) twice daily (BID) for 60 days in the absence of disease progression or unacceptable toxicity. Patients may receive standard of care (SOC) erectile dysfunction treatment during follow up. Additionally, patients may undergo blood sample collection on study.
GROUP II: Starting the day after surgery, patients receive placebo PO BID for 60 days in the absence of disease progression or unacceptable toxicity. Patients may receive SOC erectile dysfunction treatment during follow up. Additionally, patients may undergo blood sample collection on study.
After completion of study treatment, patients are followed up every other week until 6 months post-surgery and at 9 and 12 months post-surgery.
Lead OrganizationBanner University Medical Center - Tucson
Principal InvestigatorRashid Sayyid
