Luminal Bladder Cancer: Testing Neoadjuvant Therapy vs Immediate Surgery in Luminal MIBC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II, two-arm randomized trial in adults with luminal subtype muscle-invasive bladder cancer. Participants receive either neoadjuvant therapy followed by cystectomy or upfront radical cystectomy. The study uses Decipher Bladder to determine genomic subtype and tracks circulating tumor DNA at multiple time points to explore disease biology and response. Primary safety endpoints include pathological upstaging (pT3-4 or positive nodes) and overall oncologic safety, while feasibility of the upfront approach is also assessed.

Why it matters

Who can join: the full rules

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.

Where it's running

• Rutgers Cancer Institute
  New Brunswick, New Jersey, United States Recruiting

Study contacts

• Principal investigator: Saum Ghodoussipour, MD — Rutgers University
• Study coordinator: Saum Ghodoussipour, MD
• Email: sg1621@cinj.rutgers.edu
• Phone: 732-235-2465

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.