OnabotulinumtoxinA for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This pilot randomized, single-blind, placebo-controlled study evaluates the feasibility, safety, and preliminary biological activity of neoadjuvant intraprostatic onabotulinumtoxinA (BOTOX®) administered before radical prostatectomy in men with high-risk localized prostate cancer. Thirty participants will be randomized 1:1 to receive a single transrectal ultrasound-guided intraprostatic injection of onabotulinumtoxinA (50 units) or placebo 6 to 8 weeks before surgery. Outcomes include feasibility metrics, safety, adverse events, pathological findings at prostatectomy, and postoperative prostate-specific antigen (PSA) levels
Who Is on the Research Team?
Brian Miles, MD
Principal Investigator
Houston Methodist Urology, Houston Methodist Research Institute
Are You a Good Fit for This Trial?
This trial is for men with high-risk prostate cancer that has not spread beyond the prostate and who are scheduled for surgical removal of the prostate. Participants must be able to undergo an injection into the prostate before surgery.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- OnabotulinumtoxinA (BOTOX®)
Trial Overview
The study tests if a single injection of BOTOX® (onabotulinumtoxinA) directly into the prostate, given 6-8 weeks before surgery, is safe and feasible compared to a placebo (salt water). Patients are randomly assigned to either group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of onabotulinumtoxinA, total dose 50 units, administered 6 to 8 weeks prior to radical prostatectomy.
A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of normal saline placebo administered in an identical volume and injection pattern 6 to 8 weeks prior to radical prostatectomy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Methodist Hospital Research Institute
Lead Sponsor
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