Muscle-Invasive Bladder CarcinomaPhase 2/3NEO-BLASTNCT06537154
NEO-BLAST: Neoadjuvant Therapy for Bladder Cancer Followed by Active Surveillance vs Treatment
A Phase 2/3 study testing Active Surveillance in people with Muscle-Invasive Bladder Carcinoma, run by Peter Black at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Muscle-Invasive Bladder Carcinoma
- What is being tested?
- Active Surveillance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 688 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jul 2025to 31 Dec 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female >18 years
- Primary urothelial or predominantly (>50%) urothelial carcinoma of the bladder with histologic evidence of muscularis propria invasion.
- Clinical stage T2-T4aN0M0 (Radiographic lymphadenopathy greater than 1.5 cm in short axis by imaging must be proven by biopsy to be free of cancer)
- No concomitant multifocal carcinoma in situ; a single focus is allowed.
- ECOG performance status 0, 1, or 2.
- Participants must be able to undergo pelvis MRI.
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- Medically appropriate candidate for radical cystectomy (assessed by uro-oncologist) or chemo-radiation (assess by radiation-oncologist and medical-oncologist)
- Participants must be candidate to received standard of care (SOC) neoadjuvant systemic treatment at time of enrolment (assessed by medical-oncologist): 4 or more cycles of cisplatin-based chemotherapy (gemcitabine/cisplatin (GC) or methotrexate/vinblastine/Adriamycin/cisplatin (MVAC) or dose-dense MVAC (ddMVAC). If SOC evolves from the time of trial design and enrolment, eligibility to any SOC NAT (for example immunotherapy and/or antibody drug conjugate, as per NCCN guideline) will be allowed.
- Adequate bladder function and/or absence of significant urethral stricture to allow cystoscopic surveillance, as evaluate by urologist.
Who cannot join
- Any component of small cell or plasmacytoid histology.
- Prior systemic chemotherapy or immunotherapy (an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) or antibody-drug conjugate (NECTIN-4, HER2 or other) : Participants who have received any previous systemic therapy for urothelial carcinoma or cytotoxic chemotherapy, immunotherapy or other targeted therapy for another malignancy within 2 year of study entry are ineligible.
- No available bladder tumor tissue from prior TURBT for tumor sequencing.
- Prior or concurrent malignancy of any other site EXCEPT for non-melanoma skin cancer OR low risk malignancy not requiring treatment (such as prostate cancer Grade Group 1 under adequate surveillance, carcinoma in situ of the breast, cervix, etc.) AND unless free of disease for ≥ 5 years. Other cancers at low risk of recurrence may be allowed after review by principal investigator.
- Prior radiation therapy for bladder cancer.
- Participants who have received experimental agents within 4 weeks of study entry.
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- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (defined by current oral or intravenous antibiotic therapy), symptomatic congestive heart failure (NYHA >2), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnancy. People of childbearing potential must have a negative serum pregnancy test before general anesthesia procedure and MRI
- No concurrent treatment on another clinical trial; supportive care trials or non-therapeutic trials (e.g., quality of life) are allowed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Vancouver Prostate Centre
Vancouver, British Columbia, V5Z 1M9
Genevieve Moreau, 604-875-4111 ext. 67898, gbaloloy@prostatecentre.com
Sarah Charlesworth, 604-875-4111 ext. 69308, scharlesworth@prostatecentre.com
About this study
Official title: Active Surveillance Versus Definitive Local Therapy for Patients Showing Clinical Complete Response Following Neoadjuvant Therapy for Muscle Invasive Bladder Cancer
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.
Read the detailed description
Purpose To assess the feasibility to randomize patients with muscle-invasive bladder cancer (MIBC) who experience a complete clinical response (cCR) following neoadjuvant therapy (NAT), as defined by negative ctDNA, negative bladder MRI and negative repeat TURBT to active surveillance vs standard of care (SOC) with definitive bladder treatment.
Hypothesis The hypothesize is that the combination of bladder re-staging with MRI, repeat biopsy and the use of ctDNA will markedly enhance the ability to identified participant who achieve an excellent response to NAT (cCR) and who could safely be offered AS.
Justification:
Cisplatin-based neoadjuvant therapy (NAT) followed by radical cystectomy (RC), or alternatively in selected patient, a combination of chemo-radiation (trimodal therapy, TMT), are the current standards of care for treatment of MIBC. However, both have significant potential toxicity that can impact quality of life. Clinical trials have demonstrated that up to 38% of patients have a pathologic complete response (pCR) to NAT. Those patients could potentially avoid RC or TMT. Unfortunately, the clinical tools to predict pCR are still considered inadequate and definitive local therapy is advised. Retrospective data and now prospective phase 2 trials have reported promising outcomes in selected patients undergoing active surveillance. A prospective randomized trial is still lacking to ensure non-inferiority of active surveillance over the standard of care.
Primary Objectives:
- Phase 2 (pilot RCT): To determine the feasibility of randomizing patients with MIBC who experience a complete clinical response (cCR) following neoadjuvant treatment, as defined by negative ctDNA, negative bladder MRI and negative repeat TURBT, to active surveillance (AS) or definitive bladder treatment (DBT; consisting of radical cystectomy (RC) or trimodal therapy (TMT)).
- Phase 3: To estimate the metastasis-free survival rate at 2 years among patients with MIBC who experience a complete clinical response (cCR) following NAT, as defined by negative ctDNA, negative bladder MRI and negative repeat TURBT and who are managed with active surveillance.
Research design:
Multi-center, phase II/III, open label randomized clinical trial
After enrolment, participants will received SOC NAT. Blood and urine specimens will be collected before or at cycle 1 day 1 of NAT. Participants will undergo conventional restaging during NAT, recommended to be done at the end of cycle 2. Conventional imaging consists of computerized tomography (CT) scan of chest/abdomen/pelvis to rule-out local or distant progression on treatment. Participants who have successfully completed the full regimen of SOC NAT, and have not been found to have progression and/or metastasis on their SOC CT scan, will then undergo the following intervention for the "clinical restaging" (CRS) (must be completed within 4 weeks after last dose of NAT):
- ctDNA from blood samples collected before and after completion of NAT.
- Restaging bladder MRI
- Urine Cytology and Cystoscopy with template bladder biopsy under anesthesia with or without site-directed bladder biopsies.
Definition of clinical complete response (cCR):
- Absence of metastasis on conventional imaging.
- Negative MRI completed within 4 weeks of last dose of systemic treatment showing absence of VI-RADS 3, 4 or 5 lesion.
- Transurethral bladder tumor resection (TURBT) with or without site-directed bladder biopsies showing absence of high-grade carcinoma ≥cT1 and/or extensive and multifocal CIS. Focal CIS and/or completely resected Ta will be included in the definition of cCR and offered randomization.
- Negative ctDNA
Participants with cCR will then be randomized to either active surveillance or definitive bladder treatment (DBT) (RC or TMT, according to patient/physician choice). Participants who do not meet all criteria of cCR will proceed with SOC and have RC or TMT under the treating investigator's care.
Participants will adhere to the following schedule of surveillance:
Cystoscopy with urine cytology (for those with preserved bladder) every 3 months for 2 years. After 2 years, follow up schedule is at the discretion of the treating physician.
Repeat chest-abdomen-pelvis imaging with CT/MRI and ctDNA at 3, 6, 12, 18 and 24 months. After 2 years, follow up schedule is at the discretion of the treating physician.
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Being tested
- Active Surveillance, Control arm - Definitive bladder treatment
- Keywords
- Muscle invasive bladder urothelial carcinoma, Bladder Cancer
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active SurveillanceProcedure or surgery
Also called Clinical restaging (utDNA, ctDNA, MRI and TURBT)
Participant found to have a cCR will be randomized to either standard of care or investigational active surveillance.
Control arm - Definitive bladder treatmentProcedure or surgery
Standard of care, consisting of radical cystectomy or chemo-radiation of the bladder
| Study group | Role | What they receive |
|---|---|---|
| cCR, Standard of care | Active comparator | Participants found to have a clinical complete response following NAT randomized to standard of care, described as "definitive bladder treatment", which consists of either radical cystectomy, or chemo-radiation of the bladder Receives: Procedure: Control arm - Definitive bladder treatment |
| cCR, Active surveillance | Experimental | Participants found to have a clinical complete response following NAT randomized to the investigational arm consisting of active surveillance. They will have have no local treatment to their bladder and will be monitored with cystoscopy, cytology and imaging (active surveillance) Receives: Procedure: Active Surveillance |
| non-cCR, standard of care | No intervention | Participants found to have residual urothelial carcinoma (not cCR) will received the standard of care definitive bladder treatment. They will received either radical cystectomy or chemo-radiation of the bladder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 24 months
Acceptance rate to treatment allocation
Rate of concordance between treatment allocated and treatment received within the first 3 months following randomization.
Measured: 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.
Measured: 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).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start28 Jul 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle-Invasive Bladder CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 688 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Black
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Peter Black, University of British Columbia
- Investigators
- Peter Black, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537154
- Sponsor's protocol ID
- H23-02447
- Acronym
- NEO-BLAST
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2024
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared publicly. The decision to not share IPD is based on considerations regarding participant privacy and confidentiality. However, data sharing may be considered on a case-by-case basis upon request and subject to approval by the Principal Investigator. Interested researchers can direct inquiries to the Principal Investigator, and each request will be evaluated to ensure compliance with participant privacy and confidentiality policies. Aggregate data and study results will be shared through publications and presentations.
Publications
St-Laurent MP, Eigl BJ, Tyldesley S, Yuan R, Chang S, Vandekerkhove G, Black PC. NeoBLAST: A Pilot Randomized Controlled Trial of Active Surveillance Versus Definitive Bladder Treatment Following Clinical Complete Response to Neoadjuvant Therapy in Muscle-invasive Bladder Cancer - Study Protocol. Eur Urol Oncol. 2026 Aug 7:S2588-9311(26)00198-7. doi: 10.1016/j.euo.2026.07.008. Online ahead of print.
PubMed 42567733
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance Versus Definitive Local Therapy for Patients Showing Clinical Complete Response Following Neoadjuvant Therapy for Muscle Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT06537154
- Acronym / sponsor ID
- NEO-BLAST / H23-02447
- Conditions
- Muscle-Invasive Bladder Carcinoma
- Keywords
- Muscle invasive bladder urothelial carcinoma, Bladder Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 688 participants (estimated)
- Lead sponsor
- Peter BlackUniversity, hospital or other
- Collaborators
- University of British Columbia, Canadian Institutes of Health Research (CIHR)
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose To assess the feasibility to randomize patients with muscle-invasive bladder cancer (MIBC) who experience a complete clinical response (cCR) following neoadjuvant therapy (NAT), as defined by negative ctDNA, negative bladder MRI and negative repeat TURBT to active surveillance vs standard of care (SOC) with definitive bladder treatment.
Hypothesis The hypothesize is that the combination of bladder re-staging with MRI, repeat biopsy and the use of ctDNA will markedly enhance the ability to identified participant who achieve an excellent response to NAT (cCR) and who could safely be offered AS.
Justification:
Cisplatin-based neoadjuvant therapy (NAT) followed by radical cystectomy (RC), or alternatively in selected patient, a combination of chemo-radiation (trimodal therapy, TMT), are the current standards of care for treatment of MIBC. However, both have significant potential toxicity that can impact quality of life. Clinical trials have demonstrated that up to 38% of patients have a pathologic complete response (pCR) to NAT. Those patients could potentially avoid RC or TMT. Unfortunately, the clinical tools to predict pCR are still considered inadequate and definitive local therapy is advised. Retrospective data and now prospective phase 2 trials have reported promising outcomes in selected patients undergoing active surveillance. A prospective randomized trial is still lacking to ensure non-inferiority of active surveillance over the standard of care.
Primary Objectives:
- Phase 2 (pilot RCT): To determine the feasibility of randomizing patients with MIBC who experience a complete clinical response (cCR) following neoadjuvant treatment, as defined by negative ctDNA, negative bladder MRI and negative repeat TURBT, to active surveillance (AS) or definitive bladder treatment (DBT; consisting of radical cystectomy (RC) or trimodal therapy (TMT)).
- Phase 3: To estimate the metastasis-free survival rate at 2 years among patients with MIBC who experience a complete clinical response (cCR) following NAT, as defined by negative ctDNA, negative bladder MRI and negative repeat TURBT and who are managed with active surveillance.
Research design:
Multi-center, phase II/III, open label randomized clinical trial
After enrolment, participants will received SOC NAT. Blood and urine specimens will be collected before or at cycle 1 day 1 of NAT. Participants will undergo conventional restaging during NAT, recommended to be done at the end of cycle 2. Conventional imaging consists of computerized tomography (CT) scan of chest/abdomen/pelvis to rule-out local or distant progression on treatment. Participants who have successfully completed the full regimen of SOC NAT, and have not been found to have progression and/or metastasis on their SOC CT scan, will then undergo the following intervention for the "clinical restaging" (CRS) (must be completed within 4 weeks after last dose of NAT):
- ctDNA from blood samples collected before and after completion of NAT.
- Restaging bladder MRI
- Urine Cytology and Cystoscopy with template bladder biopsy under anesthesia with or without site-directed bladder biopsies.
Definition of clinical complete response (cCR):
- Absence of metastasis on conventional imaging.
- Negative MRI completed within 4 weeks of last dose of systemic treatment showing absence of VI-RADS 3, 4 or 5 lesion.
- Transurethral bladder tumor resection (TURBT) with or without site-directed bladder biopsies showing absence of high-grade carcinoma ≥cT1 and/or extensive and multifocal CIS. Focal CIS and/or completely resected Ta will be included in the definition of cCR and offered randomization.
- Negative ctDNA
Participants with cCR will then be randomized to either active surveillance or definitive bladder treatment (DBT) (RC or TMT, according to patient/physician choice). Participants who do not meet all criteria of cCR will proceed with SOC and have RC or TMT under the treating investigator's care.
Participants will adhere to the following schedule of surveillance:
Cystoscopy with urine cytology (for those with preserved bladder) every 3 months for 2 years. After 2 years, follow up schedule is at the discretion of the treating physician.
Repeat chest-abdomen-pelvis imaging with CT/MRI and ctDNA at 3, 6, 12, 18 and 24 months. After 2 years, follow up schedule is at the discretion of the treating physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cCR, Standard of care | Active comparator | Procedure: Control arm - Definitive bladder treatmentParticipants found to have a clinical complete response following NAT randomized to standard of care, described as "definitive bladder treatment", which consists of either radical cystectomy, or chemo-radiation of the bladder |
| cCR, Active surveillance | Experimental | Procedure: Active SurveillanceParticipants found to have a clinical complete response following NAT randomized to the investigational arm consisting of active surveillance. They will have have no local treatment to their bladder and will be monitored with cystoscopy, cytology and imaging (active surveillance) |
| non-cCR, standard of care | No intervention | –Participants found to have residual urothelial carcinoma (not cCR) will received the standard of care definitive bladder treatment. They will received either radical cystectomy or chemo-radiation of the bladder. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female >18 years
- Primary urothelial or predominantly (>50%) urothelial carcinoma of the bladder with histologic evidence of muscularis propria invasion.
- Clinical stage T2-T4aN0M0 (Radiographic lymphadenopathy greater than 1.5 cm in short axis by imaging must be proven by biopsy to be free of cancer)
- No concomitant multifocal carcinoma in situ; a single focus is allowed.
- ECOG performance status 0, 1, or 2.
Key exclusion criteria (9 listed)
- Any component of small cell or plasmacytoid histology.
- Prior systemic chemotherapy or immunotherapy (an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) or antibody-drug conjugate (NECTIN-4, HER2 or other) : Participants who have received any previous systemic therapy for urothelial carcinoma or cytotoxic chemotherapy, immunotherapy or other targeted therapy for another malignancy within 2 year of study entry are ineligible.
- No available bladder tumor tissue from prior TURBT for tumor sequencing.
- Prior or concurrent malignancy of any other site EXCEPT for non-melanoma skin cancer OR low risk malignancy not requiring treatment (such as prostate cancer Grade Group 1 under adequate surveillance, carcinoma in situ of the breast, cervix, etc.) AND unless free of disease for ≥ 5 years. Other cancers at low risk of recurrence may be allowed after review by principal investigator.
- Prior radiation therapy for bladder cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active SurveillanceAlso: Clinical restaging (utDNA, ctDNA, MRI and TURBT)Participant found to have a cCR will be randomized to either standard of care or investigational active surveillance. | Procedure or surgery | cCR, Active surveillance |
| Control arm - Definitive bladder treatmentStandard of care, consisting of radical cystectomy or chemo-radiation of the bladder | Procedure or surgery | cCR, Standard of care |
Primary outcome
Proportion of patients found to have a cCR and randomized on the number of patients enrolled (pilot-RCT ; phase 2)
Time frame: 24 months
Feasibility to randomized patients with cCR to either active surveillance or definitive bladder treatment.
Metastasis free survival at 2 years (phase 3)
Time frame: 24 months
Time to metastasis, defined as >cN1 (more than 1 clinically suspicious lymph nodes), cT4a (unresectable disease), or M1 disease or death.
6 secondary outcomes
Bladder-intact event-free survival
Time frame: 24 months
Proportion of cCR patient with ypT0
Time frame: 24 months
Overall survival
Time frame: 24 months
Acceptance rate to treatment allocation
Time frame: 6 months
Quality of life measure by EORTC-QLQ-C30 in participants according to treatment received
Time frame: 24 months
Quality of life measure by EORTC QLQ BLM-30 in participants according to treatment received
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Derived from this study: PubMed 42567733St-Laurent MP, Eigl BJ, Tyldesley S, Yuan R, Chang S, Vandekerkhove G, Black PC. NeoBLAST: A Pilot Randomized Controlled Trial of Active Surveillance Versus Definitive Bladder Treatment Following Clinical Complete Response to Neoadjuvant Therapy in Muscle-invasive Bladder Cancer - Study Protocol. Eur Urol Oncol. 2026 Aug 7:S2588-9311(26)00198-7. doi: 10.1016/j.euo.2026.07.008. Online ahead of print.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared publicly. The decision to not share IPD is based on considerations regarding participant privacy and confidentiality. However, data sharing may be considered on a case-by-case basis upon request and subject to approval by the Principal Investigator. Interested researchers can direct inquiries to the Principal Investigator, and each request will be evaluated to ensure compliance with participant privacy and confidentiality policies. Aggregate data and study results will be shared through publications and presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Black, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Active Surveillance in people with Muscle-Invasive Bladder Carcinoma, run by Peter Black at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Pier St-Laurent, MD (604-875-5003, mst-laurent@prostatecentre.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients found to have a cCR and randomized on the number of patients enrolled (pilot-RCT ; phase 2) (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06537154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.