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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to 90 Years
• SexAll
• Healthy volunteersNo

You may be able to join if

• ▪ 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.

You cannot join if

• 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Neoadjuvant Therapy (Drug): Patients will undergo standard of care neoadjuvant therapy followed by radical cystectomy
• Upfront radical cystectomy (Procedure): Patients will undergo upfront radical cystectomy without neoadjuvant therapy

Randomized · Parallel · masking: None

Main goals

• : Pathological upstaging rate at radical cystectomy (pT3-pT4 or pN+) (At the time of radical cystectomy)

Other goals

• Change From Baseline in Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) Bladder Cancer Subscale (BlCS) Score

Planned enrollment: 60 (estimated).

• Rutgers Cancer Institute, New Brunswick, New Jersey

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07762586

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 12, 2026. Public record; not medical advice.