NEO-BLAST: Neoadjuvant Therapy for Bladder Cancer Followed by Active Surveillance vs Treatment
NCT Number: NCT06537154
Acronym: NEO-BLAST
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Muscle-Invasive Bladder Carcinoma
Interventions: PROCEDURE: Active Surveillance|PROCEDURE: Control arm - Definitive bladder treatment
Sponsor: Peter Black
Collaborators: University of British Columbia|Canadian Institutes of Health Research (CIHR)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 688
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2028-12-31
Locations: Marie-Pier St-Laurent, Vancouver, British Columbia, V5Z 1M9, Canada

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 and urine, 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.

Primary Outcome Measures: Proportion of patients found to have a cCR and randomized on the number of patients enrolled (pilot-RCT ; phase 2), Feasibility to randomized patients with cCR to either active surveillance or definitive bladder treatment., 24 months|Metastasis free survival at 2 years (phase 3), Time to metastasis, defined as \>cN1 (more than 1 clinically suspicious lymph nodes), cT4a (unresectable disease), or M1 disease or death., 24 months
Secondary Outcome Measures: Bladder-intact event-free survival, Time from study entry to the earliest of histologically proven presence of MIBC (≥T2), clinical evidence of nodal or metastatic disease, radical cystectomy, or death due to any cause., 24 months|Proportion of cCR patient with ypT0, Rate of ypT0 (pathologic complete response) on cystectomy specimen following NAT in participants who had a cystectomy after identification of cCR., 24 months|Overall survival, Time from study entry to death; individuals who are alive at last contact will be censored on the date of last contact., 24 months|Acceptance rate to treatment allocation, Rate of concordance between treatment allocated and treatment received within the first 3 months following randomization., 6 months|Quality of life measure by EORTC-QLQ-C30 in participants according to treatment received, European Organisation for Research and Treatment of Cancer QLG Core Questionnaire (EORTC QLQ-C30). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher (better) response level and quality of life., 24 months|Quality of life measure by EORTC QLQ BLM-30 in participants according to treatment received, European Organisation for Research and Treatment of Cancer - Muscle-Invasive Bladder Cancer Module 30 (EORTC QLQ BLM-30). All of the Multi-item scales and Single-item measures range in score from 0 to 100. A high score for all of the Multi-item scales excluding Sexual functioning, and for the Single item, represents a high level of symptomatology or problems (worse outcome), whereas a high score for the Sexual functioning scale represents a high level of functioning (better outcome)., 24 months