Neoadjuvant Intraprostatic OnabotulinumtoxinA Before Radical Prostatectomy for High-Risk Localized Prostate Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor: The Methodist Hospital Research Institute
Study ID: NCT07796490
Phase: PHASE1/PHASE2
Status: Not Yet Recruiting

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Conditions

Prostate Cancer

Eligibility Criteria

Sex: MALE
Age: 45 Years - 80 Years
Healthy Volunteers: Not accepted

Interventions

OnabotulinumtoxinA (BOTOX®) — DRUG
A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of onabotulinumtoxinA, total dose 50 units, administered 6 to 8 weeks prior to radical prostatectomy.
Normal Saline Placebo — OTHER
Participants randomized to the placebo arm will receive a single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of normal saline administered in an identical volume and injection pattern as the active treatment arm, 6 to 8 weeks prior to planned radical prostatectomy.

Study Details

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

Key Dates

First listed: Sep 1, 2026
Start date: Nov 1, 2026
Status verified: Aug 2026
Primary completion: Nov 1, 2028
Completion: Nov 1, 2029

Study Design

Enrollment: 30 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Botox
A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of onabotulinumtoxinA, total dose 50 units, administered 6 to 8 weeks prior to radical prostatectomy.
Placebo Comparator: Placebo
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.