ordic Urothelial Cancer Research Group Study on Reduced BCG Dwell-Time in High Risk NMIBC

Aarhus University Hospital0 sites101 target enrollmentJune 20, 2023

Conditionsrothelial cancer Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: rothelial cancer
Sponsor: Aarhus University Hospital
Enrollment: 101
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 20, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Aarhus University Hospital

Eligibility Criteria

Inclusion Criteria

•above 18 of age at the time of signing the informed consentform, Signed informed consent form, Patients with NMIBC where BCG therapy including maintanence 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 tumours; 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 instillation with the last 2 years, due to risk of not having vcleared potential previous side effects, Patient with visible hematuria, Current alcohol and/or drug abuse, T1 tumors where re\-resection has not been performed, Mental or legal incapatitation or another condition which impair the subjects ability to participate, Participation in another interventional clinical study and treatment with another investigational product 30 days prior to randomization, Pregnancy or breastfeeding, TURB, bladder biopsy or traumatic catheterization with 2 weeks, Previous or current MIBC, Progression, defuned as progression to T1\-, T2\+ tumour or cystectomy irrespectively of indication or developement of metastatic urothelial cancer irrespectively of tumour stage, Contraindications to BCG, Immune suppressingmedication (cancer therapy e.g. cytostatic medicinal products, radiation, local and systemic steroids e.g. prednisolone is permitted), Incontinence, Need for catheter at the time of instillation, Bilateral nephrostomy catheters; unilateral nephrostomy catherter is allowed IF permanent for the duration of all istillations with BCG AND a normally functioning kidney, Female study subjects of childbearing age: unless they use highly effective methods of contraception from the first BCG instillations untill 14 days after last dose of BCG treatment, difined as total abstinence, female sterilization, oral contraceptives, or intrauterine contraceptive device, Male study subjects; unless they use highly effective methods of contraception from the first BCG instillation until 14 days after the last dose pf BCG treatment, defined as toatl abstinence or use of condoms, Reduced immune response (leukaemia, lymphoma), Known allergy to BCG, Hiv infection if untreated or uncontrolled, Signs of active tuberculosis, Any type of previous radiation therapy involving the bladder, Concomitant invasive cancer within 5 years other than non\-melanoma skin cancer and prostate cancer without metastasis, Current urinary tract infection