NCT07796490Not yet recruitingPhase 1/2
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 · Last updated 2 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 20 Aug 2026
- Start date
- Nov 2026
- Primary completion date
- Nov 2028
- Lead sponsor
- The Methodist Hospital Research Institute
- Diseases
- Prostate cancer
- NCT number
- NCT07796490
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From Nov 2026 to the primary completion date, Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior prostate cancer therapy (radiation, ADT, chemotherapy)
- Medications significantly affecting neuromuscular transmission (clinically relevant)
Other illness
- Metastatic disease
- Known hypersensitivity to botulinum toxin
- Neuromuscular disorders (e.g., myasthenia gravis)
- Active infection, coagulopathy, or contraindication to transperineal injection
- Any condition compromising safety or protocol compliance
Who the study is looking for
- 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
Age in the registry: 45 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Houston Methodist Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.