NCT06537154 · ClinicalTrials.gov record · last posted 2025-07-30
NEO-BLAST: Neoadjuvant Therapy for Bladder Cancer Followed by Active Surveillance vs Treatment
Study acronym: NEO-BLAST
StatusRecruiting
PhasePhase 2/3
Started2025-07-28
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from the ClinicalTrials.gov record
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.
Amendment record
3 amendments on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended 3 times since 2024-08-01; most recent amendment 2025-07-28. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
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2025-07-28
Status change Not Yet Recruiting→Recruitingv3
| NCT Number |
NCT06537154 |
| Lead Sponsor |
Peter Black
Collaborators: University of British Columbia, Canadian Institutes of Health Research (CIHR) |
| Conditions |
Muscle-Invasive Bladder Carcinoma |
| Enrollment |
688 participants |
| Start Date |
2025-07-28 |
| Primary Completion |
2028-12-31 (estimated) |
| Study Completion |
2030-12-31 (estimated) |
| Updated on ClinicalTrials.gov |
2025-07-30 |