Can a shorter bladder cancer treatment time cut side effects?
NCT ID NCT04701151
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether reducing the time BCG stays in the bladder (dwell-time) can lessen severe side effects in people with high-risk non-muscle invasive bladder cancer. About 314 patients from Nordic countries will either get the standard dwell-time or a shorter one based on their side effect severity. The goal is to help more patients complete their full treatment plan and lower the chance of cancer coming back.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bacillus Calmette Guerin (BCG)
- What this could lead to
- If it works, this could offer a way to manage severe side effects from BCG therapy, helping more patients finish their full treatment course and potentially reduce cancer recurrence.
- What could go wrong
- This is a phase 4 study focused on side effects, not on proving the treatment works better. Reducing dwell-time might not ease side effects for everyone, and it could still affect how well the BCG fights 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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 314 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2021
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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: * ≥18 years of age at the time of signing the Informed Consent Form * Signed Informed Consent Form * Patients with NMIBC where BCG therapy including maintenance for 1 year is planned for one of the following histopathological findings: * Ta high grade without CIS * CIS with or without previous or concomitant Ta tumors * T1 with or without CIS * Is, according to the Investigator's judgement, able to comply with the trial protocol * Ability to understand the Patient Information Sheet orally and in writing Exclusion Criteria: * Previous BCG instillations within the last 2 years, because of the risk of not having cleared potential previos side effects. * T1 tumors where re-resection had not been performed * TUR-B, bladder biopsy or traumatic catheterization within 2 weeks. * Previous or current MIBC * Progression defined as progrssion to T1-tumour, T2+\_tumour or cystectomy irrespectievely of indication or development of metastatic urothelial cancer irrespectively of tumour stage * Contraindications to BCG * Incontinence * Bilateral nephrostomy catheters; unilateral nephrostomy catheter is allowed if permanent for the duration of all inistallations with BCG and a normally functioning kidney. * Need for catheter a demeure at the time of instillation * Immune Suppressing medication (cancer therapy e.g cytostatic medicinal products, radiation, local and systemic steroids like e.g. prednisolone is permitted) * Reduced immune response (leukaemia, lymphoma) * Known allergy or sensitivity to BCG * HIV infection * Signs of active tuberculosis * Any type of previosly radiation therapy involving the bladder. * Concomitant invasive cancer within 5 years other than non-melanoma skin cancer and protate cancer without metastasis * Current urinary tract infection * Patient with visible hematuria * Current alcohol and/or drug abuse * Has a mental or legal incapacitation or another condition which impair the subject's ability to participate * Has participated in another interventional clinical study and treatment with another investigational product 30 days prior to randomization * For women study subjects: Pregnancy or breastfeeding * For women Study subjects of childbearing potential: unless they are using highly effective methods of contraception from the first BCG instillations until 14 days after last dose of BCG treatment, which are defined as total abstinence, female sterilization, use of oral methods of contraception or placement of an intrauterine contraception devices. * For male Study Subjects: unless they are using highly effective methods of contraception from the first BCG instillation until for 14 days after last dose of BCG treatment, which is defined as total abstinence or use of condoms.
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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.
Contacts and locations
Locations
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Aarhus University Hospital
Aarhus, Aarhus N, 8200, Denmark
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Department of Urology, Aalborg University Hospital
Aalborg, 9100, Denmark
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Department of Urology, Rigshospitalet
Copenhagen, 2100, Denmark
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Herlev Hospital
Herlev, Denmark
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Karolinska University Hospital
Stockholm, 141-86, Sweden
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Landspitali University Hospital
Reykjavik, 101, Iceland
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Odense University Hospital
Odense, 5000, Denmark
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PO Sahlgrenska Universitetssjukhuset
Gothenburg, sw 413 45, Sweden
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Regional Hospital Gødstrup
Herning, 7400, Denmark
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Zealand University Hospital
Roskilde, 4000, Denmark
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Örebro University Hospital
Örebro, 701 85, Sweden
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Lab-Grown tumor organoids could pick the right bladder chemo
- Can heated saline during bladder surgery stop tumors from coming back?
- Radiation instead of bladder removal: a new option for Hard-to-Treat bladder cancer?
- Can an immunotherapy plus chemotherapy keep High-Risk bladder cancer at bay?
- Can a bladder rinse before surgery keep bladder cancer at bay?
- Timing chemotherapy around bladder surgery may cut recurrence