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Botox before the scalpel: a new angle on High-Risk prostate cancer

NCT ID NCT07796490

Disease control Sponsor: The Methodist Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This pilot study tests whether injecting Botox into the prostate a few weeks before surgery can improve outcomes for men with high-risk localized prostate cancer. Thirty men will receive either a single Botox injection or a placebo, then undergo standard prostate removal surgery. Researchers will check if the injection is safe, feasible, and whether it affects tumor features or PSA levels after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OnabotulinumtoxinA (Botox), injected into the prostate before surgery
What this could lead to
If it works, this could point toward a way to improve surgical outcomes and reduce the risk of cancer recurrence in men with high-risk prostate cancer.
What could go wrong
This is a small early-stage pilot study, so results may not apply broadly. Botox injections carry risks like pain, infection, or unintended muscle weakness, and the treatment might not affect the cancer.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 80 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Houston Methodist

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.