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

About

Brief Summary

Bladder cancer is the most common urinary tract cancer and the 5th most common cancer in the US (1). Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) for Bladder Cancer Study has the potential to fill these critical evidence gaps, change care pathways for the management of NMIBC (non-muscle-invasive bladder cancer), and provide for personalized, patient-centered care. The purpose of CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with BCG (Bacillus Calmette-Guerin) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).

Study Type
Observational
Phase
N/A

Eligibility

Gender
All
Minimum Age
18 Years
Maximum Age
N/A

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., ASA of 4);
  • 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 or any blinded interventional trial for NMIBC.

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Study Stats
Protocol No.
19-001753
Category
Oncology
Urology
Contact
KRISTEN WILLIAMS
For Providers
NCT No.
NCT03933826
For detailed technical eligibility, visit ClinicalTrials.gov.