NORTH-REG Dwell-Time Study
Side Effect of Drug
About this trial
This is an interventional treatment trial for Side Effect of Drug
Eligibility Criteria
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
- T1 tumors where re-resection had not been performed
- TUR-B, bladder biopsy or traumatic catheterization within 2 weeks.
- Previous or current MIBC
- Previous or current metastatic urothelial carcinoma
- Contraindications to BCG
- Incontinence
- 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
- Previously radiation therapy of the bladder
- Known with another cancer diagnosis, except prostate cancer
- 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.
Sites / Locations
- Aarhus University HospitalRecruiting
- Department of Urology, Aalborg University HospitalRecruiting
- Herlev HospitalRecruiting
- Regional Hospital GødstrupRecruiting
- Department of Urology, Rigshospitalet
- Odense University HospitalRecruiting
- Zealand University HospitalRecruiting
- Landspitali University HospitalRecruiting
- PO Sahlgrenska UniversitetssjukhusetRecruiting
- Karolinska University HospitalRecruiting
- Örebro University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intervention
Control
Study Subjects randomized to the interventional arm will be assigned to BCG induction therapy once-weekly for 6 weeks and subsequent 1 year of maintenance (6+3x3) of which dwell-time during the first of the 6 induction instillations is 2 hours. If side effects are registered before the second and all further instillations, Study Subject in the intervention arm will be reduced in dwell-time according to the grading of side effects as given by the study algorithm.
The Study Subjects will be treated according to guidelines with BCG instillation therapy once weekly for 6 weeks and subsequent 1 year of maintenance therapy (6+3x3) with 2 hours of dwelltime.