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

Conditions

• Bladder Cancer
• Cancer of the Bladder, Recurrent
• Non-muscle Invasive Bladder Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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 non-muscle-invasive bladder cancer (NMIBC), 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 Bacillus Calmette-Guerin (BCG) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).

Key Dates

Start date

Jul 9, 2019

Status verified

Apr 2026

Primary completion

Jan 31, 2025

Completion

Jun 30, 2029

Study Design

Enrollment

570 participants (actual)

Arms

• Arm: Patients who have selected radical cystectomy
  Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
• Arm: Patients who have selected bladder-sparing therapy
  Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)

Primary Outcome Measure

Patient-reported Quality of Life as Measured by the Physical Function Scale of the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30) [ Time Frame: 12 months after enrollment ]

Locations (36)

Find similar trials in Birmingham, AL

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