The Methodist Hospital Research Institute
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
High-risk localized prostate cancer is associated with a substantial risk of adverse pathological features and disease recurrence despite definitive treatment with radical prostatectomy. Emerging evidence suggests that neural signaling within the prostate tumor microenvironment contributes to tumor growth, progression, and treatment resistance. OnabotulinumtoxinA (BOTOX®), a neurotoxin that blocks acetylcholine release, has demonstrated biological effects in prostate tissue and may provide a novel approach to modulating tumor-associated neural pathways. This single-center, prospective, random…
Inclusion Criteria: * Male, ≥ 45 years * Histologically confirmed prostate adenocarcinoma * Gleason score ≥8 on biopsy * Candidate for and scheduled to undergo RALP for primary treatment * ECOG 0-2 * Able to read, speak, and understand English * Able to provide informed consent Exclusion Criteria: * Prior prostate cancer therapy (radiation, ADT, chemotherapy) * Metastatic disease * Known hypersensitivity to botulinum toxin * Neuromuscular disorders (e.g., myasthenia gravis) * Active infection, coagulopathy, or contraindication to transperineal injection * Medications significantly affecting…
A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of onabotulinumtoxinA, total dose 50 units, administered 6 to 8 weeks prior to radical prostatectomy.
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.
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