CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer

A regiszterben nem jelölt feltételek

• Patient Eligibility, Inclusion Criteria:
• Adult 18 years of age or older; and
• Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with:
  • Pathology documentation from any hospital/clinic/medical center, and
  • More than 50% urothelial carcinoma component in the specimen
• History of high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1; and
• Attempted or received induction BCG (at least 3 out of 6 instillations) at any point in time; and
• In the previous 12 months, received at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment.
  • Patient Eligibility, Exclusion Criteria:
• Any plasmacytoid or small cell (neuroendocrine) component in the pathology (past or current presentation);
• Previous history of cystectomy or radiation therapy for bladder cancer;
• Previous history of muscle-invasive bladder cancer or metastatic bladder cancer;
• Any history of upper tract urothelial carcinoma;
• Incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
• Contraindication to radical cystectomy (e.g., American Society of Anesthesiologists (ASA) physical status of 4, patient not considered a radical cystectomy candidate due to comorbidity);
• Contraindication to medical therapy (i.e., intolerant of all medical therapies);
• Unable to provide written informed consent in English;
• Unable to be contacted for research surveys;
• Planning to participate in a Phase I or Phase II interventional clinical trial for NMIBC (unless in the control/comparator arm of a Phase II trial) or any blinded interventional trial for NMIBC.