Can a bladder rinse before surgery keep bladder cancer at bay?

NCT ID NCT07804056

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 04, 2026 · Last updated Sep 04, 2026

Summary

This phase III trial tests whether giving the drug Alpha1H directly into the bladder before standard surgery lowers the risk of cancer returning in adults with low- to intermediate-risk non-muscle-invasive bladder cancer. Participants are randomly assigned to receive either six Alpha1H instillations over about a month before surgery, or standard care alone. Researchers then compare how long participants stay free of cancer events, and also track safety, quality of life, and tumor response.

What this could mean

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

Active substance
Alpha1H, a drug given directly into the bladder as a liquid, before standard surgery to remove the tumor
What this could lead to
If it works, this could offer a way to reduce the chance of bladder cancer coming back after surgery, potentially delaying or avoiding more aggressive treatments.
What could go wrong
This is an early-phase test in a specific group of patients, so the drug may not prove effective or safe. Side effects from the bladder instillations are possible, and results may not apply to all bladder cancer cases.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 194 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

Sex

Anyone

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: * Signed and dated informed consent. * Low- or intermediate-risk non-muscle-invasive bladder cancer (NMIBC) meeting one of the following definitions: * Low-risk NMIBC: Primary, solitary, Ta, low-grade, 0.5 cm to 3 cm. * Intermediate-risk NMIBC (low-to-intermediate risk subgroup per IBCG classification): * Primary multifocal (\<10 lesions), Ta, low-grade, 0.5 cm to 3 cm; * Recurrent solitary, Ta, low-grade, 0.5 cm to 3 cm; or * Recurrent multifocal (\<10 lesions), Ta, low-grade, \>1 year after previous recurrence. * Men and women aged 18 years or older. * Negative pregnancy test at screening for women of childbearing potential. * Women of childbearing potential must agree to use highly effective contraception methods throughout study participation; men of childbearing potential must refrain from donating sperm during the study. * Ability to retain bladder contents for 2 hours. Exclusion Criteria: * Patient with non-papillary tumor appearance at the time of initial cystoscopy. * Previous history of T1 or high-grade disease in recurrent tumors. * Patients with T1 or high-grade non-muscle invasive papillary bladder cancer (NMIBC). * Previous intravesical BCG immunotherapy. * Patients with any other cancer diagnosis within the last 5 years (except for skin basalioma). * Acute urinary tract infection requiring antibiotic treatment. * Prior radiotherapy or systemic chemotherapy. * WHO performance status of 3 or 4. * Any other investigational agent or non-marketed product within one month prior to Visit 1 and during the trial. * Known active HIV infection, defined as detectable HIV viral load at screening. * Active hepatitis B virus (HBV) infection, defined as hepatitis B surface antigen (HBsAg) positivity with detectable HBV DNA at screening. * Active hepatitis C virus (HCV) infection, defined as anti-HCV antibody positivity with detectable HCV RNA at screening in a patient not on stable antiviral treatment. * Any concurrent illness that may render a participant ineligible or limit compliance with study requirements. * Previously enrolled in this trial.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Fakultni nemocnice Motol a Homolka

    Prague, 15000, Czechia

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