Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)
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.
⁃ Willing and able to provide informed consent
• Age ≥18 years old
• Eligible to receive standard of care systemic neoadjuvant therapy
• Eastern Cooperative Group (ECOG) performance status of 0-1
• Documented histologically confirmed urothelial muscle-invasive bladder cancer
• cT2N0M0 bladder cancer based on pre-TURBT bimanual exam and cross-sectional imaging performed within 8 weeks of surgery or initiation of NAT.
• Willing to undergo RC with urinary diversion
• No signs of extravesical disease on pre-TURBT conventional imaging
• Variant histology is allowed so long as the tumor is predominantly urothelial carcinoma.
• No presence of LVI on TURBT
• Decipher Bladder GSC test result
• Ineligible for or refusing TMT
• No cN+
• The population is adult men or women of any ethnicity diagnosed with muscle-invasive bladder cancer.