2418 Starburst-1
PROJECT DESCRIPTION
Currently, patients diagnosed with muscle invasive bladder cancer (MIBC) are scheduled for neoadjuvant therapy (NAT) immediately followed by surgery or radiotherapy. Because radiological and endoscopic assessment of response to NAT is suboptimal, patients proceed directly to radical treatment without any local re-assessment. With the risks and complications associated with cystectomy, not to mention the body image alteration, there is a growing interest in “bladder sparing” approaches. This is not possible until clinical tools are validated to identify patients that could, if complete or near complete response were accurately diagnosed, benefit from bladder sparing strategies. This downstream project of the 1553-SPECTA platform will investigate the use of multiparametric magnetic resonance imaging and the application of a scoring system (NacVI-RADS) to assess tumour response to NAT. In addition, the presence of circulating tumour DNA and urine tumour DNA will be investigated as well as molecular classifications of MIBC to demonstrate prognostic and treatment relevance.
SB-1 aims to define a multimodal response signature based on MRI, and liquid blood and urine samples, setting the stage for future escalation / de-escalation trials in localised MIBC
Multi-parametric Magnetic Resonance Imaging (mpMRI) scans done prior to and after neo-adjuvant therapy will be collected. Central review of and scoring according to NacVI-RADS criteria will be done. Results will be sent back to sites to complement training given for application of scoring system.
- Patients with cT2-4a N0-1 M0 urothelial bladder cancer
- Age ≥ 18 years old
- To be treated with any of the available standard-of-care locally approved and reimbursed neoadjuvant treatment and willing and able to undergo radical cystectomy
- No previous systemic treatment for bladder cancer
- Signed SPECTA informed consent
At enrolment, archival TURBT FFPE material, plus blood and urine samples will be collected. Blood will be used for ctDNA analysis, urine for utDNA, and the blood reference sample may also support germline DNA analysis when applicable.
After neoadjuvant therapy, 3–4 weeks after treatment and before radical cystectomy, blood and urine will be collected again together with representative cystectomy FFPE material.
STARBURST 1 is supported by La Ligue contre le cancer as academic partner. Industry support is provided by Ferring, Veracyte and Cepheid.
Masson-Lecomte A, Grisay G, Damme JV, Achard V, Mertens LS, Boellaard TN, D’Haese D, Fournier B, Govaerts AS, Huddart R, Soria F, Dyrskjøt L, Allory Y, Pecoraro M, Litiere S, Tombal B, Panebianco V, Loriot Y. Challenges in Defining Clinical Complete Response to Systemic Therapy in Muscle-invasive Bladder Cancer: Insights from the EORTC STARBURST Project. Eur Urol Oncol. 2025 Jun;8(3):603-607. doi: 10.1016/j.euo.2025.03.005. Epub 2025 Apr 16. PMID: 40240255. https://doi.org/10.1016/j.euo.2025.03.005
LIST OF COHORTS
For SPECTA, please enroll patients with the tumor type specified in the table, ONLY when the status is green. You can enroll those patients by clicking on the 
, next to the green status.
Study specific information (HBM, Project Specific selection criteria, CRF completion guidelines…) can be found here 
. Please note that your electronic database ORTA password is required for access (protocol 1553).
For any questions, please contact the project e-mail address: 2418@eortc.org.
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