Recruiting
Phase 2

NAT vs. Cystectomy

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT07762586

Conditions

Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Neoadjuvant Therapy

Upfront radical cystectomy

Study Details

Brief 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.

Conditions

Bladder Cancer

Study ID

NCT07762586

Start date

Jul 10, 2026

Status verified date

Aug, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Neoadjuvant Systemic Therapy Followed by Radical Cystectomy

Participants receive standard-of-care neoadjuvant systemic therapy, as selected by the treating physician, followed by radical cystectomy with urinary diversion.

Interventions: Each specific drug regimen confirmed by the PI, plus Radical Cystectomy With Urinary Diversion.

experimental: Upfront Radical Cystectomy

Participants proceed directly to radical cystectomy with urinary diversion without receiving initial neoadjuvant systemic therapy.

Intervention: Radical Cystectomy With Urinary Diversion

Interventions

Neoadjuvant Therapy

Patients will undergo standard of care neoadjuvant therapy followed by radical cystectomy

Upfront radical cystectomy

Patients will undergo upfront radical cystectomy without neoadjuvant therapy

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Saum Ghodoussipour, MD

732-235-2465sg1621@cinj.rutgers.edu

Locations

Rutgers Cancer Institute

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Saum Ghodoussipour, MD

732-235-5265sg1621@cinj.rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-08-13.