This study is a two-arm phase II randomized trial investigating patients with luminal subtype muscle-invasive bladder cancer (MIBC) receiving neoadjuvant therapy (NAT) followed by cystectomy compared to those receiving upfront cystectomy.
▪ Inclusion Criteria
Willing and able to provide informed consent
Age ≥18 years old
Eligible to receive standard of care systemic neoadjuvant therapy
Patients under 18 years old. Considering the minimal incidence of bladder cancer among the pediatric population, children are not eligible for this study.
Not willing or unable to give informed consent.
Clinical or pathological evidence of metastatic disease, including, non-regional lymph nodes, visceral lesions, and bone lesions.
Significant hepatic impairment (Serum bilirubin > 1.5x upper limit of normal).
Parallel
Neoadjuvant Therapy
DrugPatients will undergo standard of care neoadjuvant therapy followed by radical cystectomy
Upfront radical cystectomy
Procedure/SurgeryPatients will undergo upfront radical cystectomy without neoadjuvant therapy
: Pathological upstaging rate at radical cystectomy (pT3-pT4 or pN+)
Percentage of evaluable participants in each study arm who are pathologically upstaged from clinical stage cT2N0 disease to pathological stage pT3-pT4 or pN+ disease, based on examination of the radical cystectomy specimen.
Change From Baseline in Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) Bladder Cancer Subscale (BlCS) Score
Change From Baseline in Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) Bladder Cancer Subscale (BlCS) Score
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