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
Male, ≥ 45 years
Histologically confirmed prostate adenocarcinoma
Gleason score ≥8 on biopsy
Candidate for and scheduled to undergo RALP for primary treatment
Prior prostate cancer therapy (radiation, ADT, chemotherapy)
Metastatic disease
Known hypersensitivity to botulinum toxin
Neuromuscular disorders (e.g., myasthenia gravis)
Parallel
OnabotulinumtoxinA (BOTOX®)
DrugA 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 interventionParticipants 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.
Participant Accrural
Number of participants enrolled in the study
Protocol Adherence
Proportion of participants who complete study procedures according to protocol requirements.
Successful Completion of Intraprostatic Injection
Number of participants who successfully receive the assigned intraprostatic study injection.
Incidence of Adverse Events
Incidence, severity, seriousness, and relationship of adverse events associated with intraprostatic administration of onabotulinumtoxinA or placebo.
Gleason Score at Radical Prostatectomy
Comparison of Gleason score determined from radical prostatectomy specimens between treatment arms. Gleason Score determined from radical prostatectomy specimens. Gleason Scores range from 6 to 10, with higher scores indicating more aggressive prostate cancer.
Perineural Invasion
Presence and extent of perineural invasion identified in radical prostatectomy specimens.
Stromogenic Component
Assessment of stromogenic component in radical prostatectomy specimens.
Tumor Size
Tumor size measured in radical prostatectomy specimens. The measurement will be recorded in centimeters (cm).
Time to Biochemical Recurrence
Time from radical prostatectomy to biochemical recurrence as defined by postoperative PSA progression.
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