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RECRUITING
NCT06537154
PHASE2/PHASE3

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

Sponsor: Peter Black

View on ClinicalTrials.gov

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.

Official title: Active Surveillance Versus Definitive Local Therapy for Patients Showing Clinical Complete Response Following Neoadjuvant Therapy for Muscle Invasive Bladder Cancer

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

688

Start Date

2025-07-28

Completion Date

2030-12-31

Last Updated

2025-07-30

Healthy Volunteers

No

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

Locations (1)

Vancouver Prostate Centre

Vancouver, British Columbia, Canada