Clinical trial · Interventional
Neoadjuvant Intraprostatic OnabotulinumtoxinA Before Radical Prostatectomy for High-Risk Localized Prostate Cancer
A Pilot Randomized, Single Blind, Placebo Controlled Study of Neoadjuvant Intraprostatic OnabotulinumtoxinA Prior to Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Normal Saline Placebo | Other | — | UNRESOLVED |
| OnabotulinumtoxinA (BOTOX®) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Botox
- description
- A single transperineal, transrectal ultrasound (TRUS)-guided intraprostatic injection of onabotulinumtoxinA, total dose 50 units, administered 6 to 8 weeks prior to radical prostatectomy.
- interventionNames
- Drug: OnabotulinumtoxinA (BOTOX®)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 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.
- interventionNames
- Other: Normal Saline Placebo
Primary outcomes (5)
- measure
- Participant Accrural
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available