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

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

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 neuromuscular transmission (clinically relevant) * Any condition compromising safety or protocol compliance