ORTH-REG Dwell-Time Study

Phase 1

• Conditions: rothelial cancer; Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]; Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]

• Registration Number: CTIS2023-505936-37-00
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-20
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The trial aims to evaluate the potential clinical impact of a new regimen with reduction of dwell time during once-weekly BCG instillations for 6 weeks followed by maintenance therapy for 12 months with regards to side effects, adherence to instillation regimen, and oncological outcome.;Secondary Objective: To evaluate the safety of the new regime, so that patients are not treated with an inferior treatment with risk of earlier progression and recurrence., To evaluate if there is a higher number of completed instillations, To evaluate if the treatment is more tolerated with fewer side effects both local and systemic;Primary end point(s): Number of study subjects completing all 6 induction instillations and subsequent maintenance instillations for 12 months (6+3x3)