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NEO-BLAST: Neoadjuvant Therapy for Bladder Cancer Followed by Active Surveillance vs Treatment

NCT06537154 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 688

Last updated 2025-07-30

No results posted yet for this study

Summary

Invasive bladder cancer is managed with neoadjuvant therapy followed by bladder removal (cystectomy). Research shows that approximately 40% of patient will have no remaining cancer left in their bladder after completion of the initial systemic treatment, and perhaps could have avoided the surgery. However, currently physicians lack the ability to identify these patients.

The investigators believe that by using advanced imaging (MRI), bladder biopsies and novel biomarkers that detect tumor DNA in blood, they can better identify participants without any remaining cancer after chemotherapy. This will make active surveillance of these participants safer. In this study, participants without evidence of residual cancer will be randomized to active surveillance vs conventional bladder treatment (bladder removal, or chemo-radiation of the bladder). This study will be a pilot randomized control trial (RCT), and if successful, it will transition to a larger phase 3 RCT.

Conditions

  • Muscle-Invasive Bladder Carcinoma

Interventions

PROCEDURE

Active Surveillance

Participant found to have a cCR will be randomized to either standard of care or investigational active surveillance.

PROCEDURE

Control arm - Definitive bladder treatment

Standard of care, consisting of radical cystectomy or chemo-radiation of the bladder

Sponsors & Collaborators

  • University of British Columbia

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Peter Black

    lead OTHER

Principal Investigators

  • Peter Black, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-28
Primary Completion
2028-12-31
Completion
2030-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06537154 on ClinicalTrials.gov