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ILLUMINATE Clinical Study Officially Kicks Off and Includes First Participant
The ILLUMINATE consortium has reached an important milestone: on 4 June 2026, the project's clinical study officially kicked off at UMC Utrecht, the coordinating center of the study. Moreover, on 18 June, the first patient was included in the study and sucesfully underwent a scan.
About the clinical study
The ILLUMINATE clinical study will investigate whether metabolic MRI (MeMRI) can help predict which patients with metastatic castrate-resistant prostate cancer are most likely to benefit from lutetium-177-PSMA therapy. By combining advanced imaging with radionuclide therapy, ILLUMINATE aims to support more personalised treatment decisions and improve patient outcomes.
The study will will recruit a total of 150 patients: 100 in the Netherlands and 50 in Essen, Germany.
Patients participating in the study will receive standard-of-care lutetium-177-PSMA treatment. In addition to routine imaging, ILLUMINATE will introduce metabolic MRI as part of a multimodal theranostics approach.
Patients may receive up to six treatment cycles, with imaging assessments performed at baseline and after every two treatment cycles. During this period, participants will undergo metabolic MRI-scans alongside routine PSMA PET/CT imaging, allowing researchers to investigate whether metabolic changes can help predict treatment response earlier and more accurately.
The insights generated through the study could contribute to more personalised treatment strategies and help avoid unnecessary treatment for patients who are unlikely to benefit.
Find out more about the ILLUMINATE clinical study here.
Kick off and start of patient recruitment
The kick-off meeting brought together the study team from UMC Utrecht - the principal investigator and nuclear physician, study coordinators and PhD student, as well as members of the ILLUMINATE Stakeholder Involvement Community (STIC) to align on the study procedures, patient journey, technical requirements, and operational aspects of the trial. Participants discussed the study protocol, reviewed instructions for clinical staff, and identified key points requiring attention during study execution and monitoring.
On 18 June, the first patient was included in the study and sucesfully scanned. Two additional eligible patients have already been informed about the study and expressed their willingness to participate.
Shanta Kalaykhan-Sewradj (UMC Utrecht), ILLUMINATE Clinical Study CoordinatorThe study kick-off marked the start of an exciting new phase for ILLUMINATE. It gave us the opportunity to ensure that all teams were ready to begin patient recruitment, and we are delighted that the first participant has already been included and successfully scanned.
Patient involvement from the start
Patient and healthcare professional representatives from ILLUMINATE's STIC have played an important role in preparing the study.
Throughout the study design process, STIC-members provided recommendations on patient-facing materials, reviewed participant information documents, advised on questionnaires, and shared insights on how the study could best accommodate the needs and experiences of patients.
Their contributions have helped ensure that the study is not only scientifically robust, but also patient-centred.
Read more about Patient and Public Involvement in ILLUMINATE and the STIC here.
Next steps
Over the coming months, the consortium will focus on enrolling participants across the study sites and generating the evidence needed to assess the value of metabolic MRI in predicting treatment response.
With the study now underway, ILLUMINATE takes an important step towards advancing personalised prostate cancer care across Europe.