Can a bladder rinse before surgery keep bladder cancer at bay?
NCT ID NCT07804056
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 194 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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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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
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Fakultni nemocnice Motol a Homolka
Prague, 15000, Czechia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an immunotherapy plus chemotherapy keep High-Risk bladder cancer at bay?
- Timing chemotherapy around bladder surgery may cut recurrence
- Can a glowing dye reveal hidden bladder cancer during surgery?
- Can a chemo gel spare the bladder in cancer?
- Mapping bladder cancer care: a nationwide look at Real-World treatment
- AI reads tumor images to forecast bladder cancer treatment response