NORTH-REG Dwell-Time Study

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Previous studies show that the majority NMIBC patients experience side effects to BCG and therefore terminate the instillations before completing all planned instillations. This will increase their risk of recurrence and potential cystectomy. The purpose of this study is to investigate if NMIBC patients who experience severe side effects to BCG instillations will experience fewer or less severe side effects if reducing dwell-time of BCG instillations.

The study will include patients from Denmark, Iceland, Norway and Sweden.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jørgen Bjerggaard Jensen
• Collaborators: Aalborg University Hospital; Aarhus University Hospital; Herlev Hospital; Landspitali University Hospital; Odense University Hospital; Region Örebro County; Regional Hospital West Jutland; Rigshospitalet, Denmark; Sahlgrenska University Hospital, Sweden; The Hospital of Vestfold; Zealand University Hospital
• Treatments: BCG Vaccine

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.