Perioperative systemic therapies in muscle-invasive bladder cancer (GUARDIANS)
Official title: Perioperative GUARDIANS Project: Real-World Evaluation of Feasibility, Toxicity, and Oncologic Outcomes of Perioperative Systemic Therapies in Muscle-Invasive Urothelial Carcinoma
Run by LMU Klinikum · NCT07855926 · Data updated 2026-11-12
This registry will see how real-world perioperative treatments for muscle-invasive bladder cancer work in adults, including regimens like Enfortumab Vedotin with Pembrolizumab and cisplatin-based plans.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | LMU Klinikum Academic / other |
| Drugs / interventions | Enfortumab, Pembrolizumab, Durvalumab, chemotherapy, immunotherapy |
| Locations | 1 site (Munich) |
| Status | Recruiting |
| Started | May 17, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | May 31, 2029 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT07855926 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with muscle-invasive or locally advanced urothelial carcinoma of the bladder planning or receiving perioperative systemic therapy and undergoing radical cystectomy.
✕Probably not a fit
Patients not receiving perioperative systemic therapy or without follow-up data may not contribute to the primary endpoints.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
GUARDIANS is a multicenter observational registry collecting real-world data on perioperative systemic therapies for muscle-invasive or locally advanced urothelial bladder cancer. It tracks adults treated in routine care, from baseline through neoadjuvant therapy, cystectomy, and potential adjuvant treatment, with long-term follow-up. Key outcomes include event-free survival, pathologic response, disease-free and overall survival, perioperative safety, and treatment-related adverse events, along with patient-reported neurotoxicity. The study aims to understand feasibility, dose intensity, and comparative outcomes across treatment approaches. Data will be analyzed to describe real-world implementation and long-term oncologic outcomes of these perioperative strategies.
Why it matters
Potential benefit: If successful, the registry could clarify which perioperative therapies are feasible and effective in real-world practice, informing future care decisions for patients.
How similar studies have gone: Real-world data registries have previously shown value in understanding perioperative treatment patterns and safety in bladder cancer, but specifics of antibody-drug conjugate–based regimens are still emerging.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Histologically confirmed muscle-invasive or locally advanced urothelial carcinoma of the bladder * Planned, ongoing, or completed perioperative systemic therapy, including but not limited to Enfortumab Vedotin plus Pembrolizumab, Gemcitabine/Cisplatin/Durvalumab, cisplatin-based chemotherapy, immunotherapy, or other standard perioperative treatment approaches * Radical cystectomy planned or performed as part of curative-intent treatment strategy * Written informed consent for prospective data collection, where required * Sufficient clinical documentation available for retrospective inclusion, including at least one follow-up assessment Exclusion Criteria: * Missing informed consent where prospectively required * Insufficient documentation of key baseline data or treatment exposure * No perioperative systemic therapy or inability to assign patient to a study cohort * Follow-up data unavailable or inconsistent documentation preventing endpoint assessment
Where it's running
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Department of Urology, LMU University Hospital Munich
Munich, Germany Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.