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

Summary

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.

Eligibility

Inclusion Criteria:

* ▪ 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.

Exclusion Criteria:

* 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).
* Significant renal impairment (creatinine clearance \<30 ml/min).
* Predominant variant histology (i.e. nested, micropapillary, sarcomatoid, plasmacytoid, small cell)6
* 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.
* 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.
* Any medical, familial, psychiatric, or geographic considerations that may prevent patients from study participation or follow-up required by the study protocol
* Patients (cN+) are excluded from participation and are not eligible for enrollment.
* Prisoners, Individuals without Decisional Capacity, and Pregnant Women will be excluded.

Conditions2

Interventions1

Locations1 site

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