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Not yet recruitingPhase 1 / Phase 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 80 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound, Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether a BOTOX injection into the prostate is safe, practical, and shows early effects on cancer. It is for men age 45 or older with high-risk prostate cancer that has not spread, who are scheduled for prostate removal surgery. Men will be assigned by chance to receive BOTOX or a placebo (an injection with no active drug) 6 to 8 weeks before surgery.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Male and age 45 or older.
  • Have prostate adenocarcinoma, a type of prostate cancer, confirmed by a tissue sample.
  • Have a Gleason score of 8 or higher on biopsy, a sign the cancer may grow quickly.
  • Be eligible and scheduled for robot-assisted prostate removal surgery as the first cancer treatment.
  • Have an ECOG score of 0 to 2: be able to care for yourself and be up and about at least half the day.
  • Be able to read, speak, and understand English.
  • Be able to understand the study and give consent to join.

Who can't join

  • Have had prostate cancer treatment, such as radiation, hormone-lowering treatment, or chemotherapy.
  • Have cancer that has spread to other parts of the body.
  • Have a known allergy to botulinum toxin, the drug in BOTOX.
  • Have a nerve or muscle disorder, such as myasthenia gravis, which causes muscle weakness.
  • Have an active infection, a blood-clotting problem, or a reason you cannot safely have an injection through the skin between the scrotum and anus.
  • Take medicines that greatly affect how nerves send signals to muscles.
  • Have any condition that makes joining unsafe or prevents following study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

TX