Recruiting
Phase 2
Phase 3

Active Surveillance vs. Treatment

Sponsor:

Peter Black

Code:

NCT06537154

Conditions

Muscle-Invasive Bladder Carcinoma

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Active Surveillance

Control arm - Definitive bladder treatment

Study Details

Brief 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.

Conditions

Muscle-Invasive Bladder Carcinoma

Study ID

NCT06537154

Start date

Jul 28, 2025

Status verified date

Jul, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

688 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: cCR, Standard of care

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

experimental: cCR, Active surveillance

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)

no intervention: non-cCR, standard of care

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.

Interventions

Active Surveillance

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

Control arm - Definitive bladder treatment

Standard of care, consisting of radical cystectomy or chemo-radiation of the bladder

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 ]
  • Metastasis free survival at 2 years (phase 3) [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Marie-Pier St-Laurent, MD

604-875-5003mst-laurent@prostatecentre.com

Jacquie Stevenson

604-875-5003jstevenson@prostatecentre.com

Locations

Vancouver Prostate Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Genevieve Moreau

604-875-4111gbaloloy@prostatecentre.com

Sarah Charlesworth

604-875-4111scharlesworth@prostatecentre.com

Principal Investigator:

Marie-Pier St-Laurent, MD

More Information

Sponsor

Peter Black

Last update posted

Jul 30, 2025

Last verified

Jul, 2025

Keywords

  • Muscle invasive bladder urothelial carcinoma
  • Bladder Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Peter Black on 2025-07-30.