Actively Recruiting
NEO-BLAST: Neoadjuvant Therapy for Bladder Cancer Followed by Active Surveillance vs Treatment
Led by Peter Black · Updated on 2025-07-30
688
Participants Needed
1
Research Sites
283 weeks
Total Duration
On this page
Sponsors
P
Peter Black
Lead Sponsor
U
University of British Columbia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
NEO-BLAST: Neoadjuvant Therapy for Bladder Cancer Followed by Active Surveillance vs Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female older than 18 years
- Primary urothelial or mostly urothelial bladder cancer invading muscle
- Clinical stage T2 to T4aN0M0 without confirmed lymph node cancer
- No multiple areas of carcinoma in situ; single focus allowed
- ECOG performance status of 0, 1, or 2
- Able to have pelvic MRI
- Medically suitable for radical cystectomy or chemo-radiation
- Eligible for standard neoadjuvant systemic treatment including cisplatin-based chemotherapy
- Adequate bladder function and no significant urethral narrowing to allow cystoscopic surveillance
You will not qualify if you...
- Any small cell or plasmacytoid histology
- Prior systemic chemotherapy, immunotherapy, or antibody-drug conjugate for bladder cancer or recent systemic therapy for other cancers within 2 years
- No available bladder tumor tissue from prior resection for sequencing
- Prior or concurrent other cancers except certain low-risk types free for 5 years
- Prior radiation therapy for bladder cancer
- Use of experimental agents within 4 weeks before study entry
- Uncontrolled illnesses such as active infection, severe heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Pregnancy or positive pregnancy test before procedures
- Concurrent participation in another therapeutic clinical trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Vancouver Prostate Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
Research Team
M
Marie-Pier St-Laurent, MD
CONTACT
J
Jacquie Stevenson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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