Neoadjuvant chemotherapy followed by watchful waiting versus immediate bladder treatment for muscle-invasive bladder cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Patients with muscle-invasive urothelial bladder cancer receive standard cisplatin-based neoadjuvant therapy and are then re-staged using pelvic MRI, repeat bladder biopsy (TURBT), and circulating tumor DNA (ctDNA) testing. Participants who have no detectable cancer by all three methods (clinical complete response) are randomized to either active surveillance or standard definitive bladder treatment (radical cystectomy or chemo-radiation). The initial phase is a pilot randomized trial to test feasibility and safety, with a planned transition to a larger phase 3 randomized trial if results support it. The goal is to determine whether combined imaging, tissue sampling, and molecular testing can reliably identify patients who may safely avoid immediate definitive bladder therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Vancouver Prostate Centre
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Principal investigator: Peter Black, MD — University of British Columbia
• Study coordinator: Marie-Pier St-Laurent, MD
• Email: mst-laurent@prostatecentre.com
• Phone: 604-875-5003

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy

  This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.

  Recruiting Phase 2 Fox Chase Cancer Center · Philadelphia, Pennsylvania · NCT07908979

• Consolidative therapy after initial response in advanced bladder cancer

  This pilot trial tests adding radiation or surgery after a good response to EV + pembrolizumab in unresectable or oligometastatic muscle-invasive bladder cancer to see if residual disease can be eliminated or delayed from growing.

  Recruiting Phase 1/2 University of Washington · Seattle, Washington · NCT07579195

• Sexual health support after bladder cancer treatment

  This project will try sexological support to help adults about 12 months after bladder cancer treatment improve sexual function and intimacy.

  Recruiting University of Aarhus · Aarhus · NCT07339761

• Ureteral stent versus no stent for adults having radical cystectomy with an ileal conduit

  This trial tests whether placing temporary ureteral stents at the time of radical cystectomy with ileal conduit reduces post-operative complications compared with not placing stents in adults having cystectomy for bladder or other pelvic cancers.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania and 1 other locations · NCT07234968

• Assessing late images in PET-CT for bladder cancer staging

  This study is testing if taking later images during a PET-CT scan can help better identify lymph node involvement in patients with muscle-invasive bladder cancer.

  Recruiting Hopital Foch · Suresnes, Île-de-France Region · NCT06537960

• Personalized cancer vaccine for patients with muscle-invasive bladder cancer

  This study is testing a personalized cancer vaccine to see if it can help patients with muscle-invasive bladder cancer fight their disease by boosting their immune response.

  Recruiting Phase 1 Washington University School of Medicine · Orlando, Florida and 2 other locations · NCT06529822

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.