Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)

Prior treatment

• Prior history of systemic treatment for non-urothelial malignancies in the past three years, including chemotherapy and immunotherapy.
• Prior diagnosis or evidence of psychiatric or medical conditions that may prevent patients from giving full and properly informed consent.

Other illness

• Clinical or pathological evidence of metastatic disease, including, non-regional lymph nodes, visceral lesions, and bone lesions.
• cT3 bladder cancer on pre-TURBT bimanual exam or with hydronephrosis on cross-sectional imaging performed within 8 weeks of surgery or initiation of NAT
• TURBT specimen with lymphovascular invasion (LVI) cT4 or unresectable bladder cancer
• Concurrent diagnoses of other, non-urothelial, malignancies or prior malignancy diagnoses within the past three years. Exceptions, determined at the discretion of the principal investigator, include squamous cell carcinoma, basal cell carcinoma, or other low-grade cancer not expected to progress or require surgical/systemic therapy.
• Any medical, familial, psychiatric, or geographic considerations that may prevent patients from study participation or follow-up required by the study protocol

Lab values

• Significant hepatic impairment (Serum bilirubin \> 1.5x upper limit of normal).
• Significant renal impairment (creatinine clearance \<30 ml/min).

Age

• Patients under 18 years old. Considering the minimal incidence of bladder cancer among the pediatric population, children are not eligible for this study.

Other

• Not willing or unable to give informed consent.
• Predominant variant histology (i.e. nested, micropapillary, sarcomatoid, plasmacytoid, small cell)6
• Patients (cN+) are excluded from participation and are not eligible for enrollment.
• Prisoners, Individuals without Decisional Capacity, and Pregnant Women will be excluded.

• ▪ Inclusion Criteria
  • 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.