RecruitingPhase 2Phase 3NCT06537154

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

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


Sponsor

Peter Black

Enrollment

688 participants

Start Date

Jul 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study (NEO-BLAST) tests whether bladder cancer patients who respond completely to chemotherapy before planned surgery can safely skip surgery and instead undergo close monitoring. The goal is to preserve the bladder in patients who achieve a full response. **You may be eligible if...** - You are 18 or older with muscle-invasive bladder cancer (cancer that has grown into the bladder muscle) - Your cancer has not spread to lymph nodes or distant organs - You are physically fit enough to undergo major surgery or chemoradiation if needed - You can have a pelvic MRI scan **You may NOT be eligible if...** - Your cancer has widespread carcinoma in situ (flat tumors at multiple sites) - You are unable to receive standard pre-surgery chemotherapy - Your performance status is too poor for the required treatment options Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREActive Surveillance

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

PROCEDUREControl 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

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NCT06537154


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