None listed
Conditions
Interventions
Drug :
- Sequence Group A (pentosan polysulfate sodium ? Non-administration): Pentosan polysulfate sodium (PPS) 100 mg orally, three times daily. Administration initiates 14 days prior to the first B
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults aged 19 years or older (both male and female). - Diagnosed with intermediate- or high-risk non-muscle-invasive bladder cancer (NMIBC) according to the WHO 2004/2022 classification (including Ta/T1 high-grade tumors or carcinoma in situ [CIS]), who are scheduled to undergo standard Bacillus Calmette-Guerin(BCG) induction therapy and the first maintenance therapy (typically at the 3-month time point, once weekly × 3 weeks) following a complete transurethral resection of bladder tumor (TURBT). - Bacillus Calmette-Guerin(BCG)-naive patients. - ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2. - Able to provide written informed consent prior to study participation, and capable of understanding and complying with the study procedures. - Women of childbearing potential must have a negative pregnancy test and agree to use adequate contraception during the study period.
Exclusion criteria
Exclusion criteria: - Muscle-invasive bladder cancer (=T2), upper tract urothelial carcinoma (UTUC), distant metastasis, or cases requiring immediate radical cystectomy as a primary indication. - Prior intravesical immunotherapy or chemotherapy, including Bacillus Calmette-Guerin, within the last 12 months. - Active urinary tract infection (UTI), fever of 38°C or higher, gross hematuria, traumatic catheterization, or any other condition where the scheduled Bacillus Calmette-Guerin instillation is contraindicated under standard of care. - Uncontrolled immunocompromised status, active tuberculosis, or a history of Bacillus Calmette-Guerin sepsis. - Known history of hypersensitivity to pentosan polysulfate sodium (PPS), heparin-like drugs, or any excipients of the investigational product. - Active hemorrhagic disease, clinically significant thrombocytopenia, a history of heparin-induced thrombocytopenia (HIT), or any high bleeding risk condition as determined by the investigator. - Pre-existing severe retinal disease, suspected pigmentary maculopathy, or any condition that hinders adequate assessment of visual changes. - Pregnant or lactating individuals. - Any other condition where the investigator deems that the subject is unable to complete both treatment periods or transition successfully to the first maintenance therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of Bacillus Calmette-Guerin(BCG) instillations associated with clinically significant local genitourinary toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Bacillus Calmette-Guerin(BCG) instillation completion rate ;The rate of Bacillus Calmette-Guerin(BCG) instillation delay (>7 days) or permanent discontinuation due to adverse events;The rate of transition to treatment period 2;The rate of permanent Bacillus Calmette-Guerin instillation discontinuation due to clinically significant local genitourinary toxicity or equivalent treatment intolerance;Changes in Numeric Rating Scale(NRS) bladder pain scores and International Prostate Symptom Score(IPSS), and European Organisation for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire-Non-Muscle-Invasive Bladder Cancer24(QLQ-NMIBC24) scores at the completion of the 6th induction instillation and the 3rd maintenance instillation;The incidence and severity (according to Common Terminology Criteria for Adverse Events(CTCAE) v5.0) of pentosan polysulfate sodium related and Bacillus Calmette-Guerin related local and systemic adverse events;Exposure-adjusted utilization rate of symptomatic medications;Recurrence rate and progression rate;Adherence to investigational product (compliance rate) | — |
Countries
Korea, Republic of
Contacts
Public ContactIn-gab Jeong
Asan Medical Center
Outcome results
None listed