Clinical study

Despite the success of lutetium-177-treatment for metastatic prostate cancer, not all patients respond to it. Around 30% of patients do not benefit from the treatment but do suffer from the side effects such as nausea and fatigue. Currently, it is impossible to predict which patient will respond to the treatment and which not. Therefore, ILLUMINATE will set up a clinical study aiming to find out objective decision criteria for treatment selection and therapy monitoring. This will contribute towards optimizing the efficacy and safety of cancer treatments.   

Current approaches used to predict and monitor treatment efficacy in prostate cancer lack key features to assess whether patients are resistant to the treatment and what causes this on a molecular level. Metabolic-MRI is a technique that makes it possible to show all chemical reactions in the body and therefore it can detect how patients respond to the lutetium-177 treatment.  

By performing its clinical study, ILLUMINATE aims to demonstrate that metabolic-MRI can improve treatment efficacy in prostate cancer through better dosing, preventing side effects, and quickly identifying patients who do not benefit from advanced treatment regimes. ILLUMINATE will provide the first clinical translation of metabolic-MRI, with application to metastatic castrate resistant prostate cancer. This Proof-of-Principle study will pave the way for future expansion of the technology for earlier cancer stages and for use in other cancer types.

Clinical study set-up 

ILLUMINATE will conduct a multi-centre observational clinical study in Essen (Germany), Utrecht (the Netherlands) and Amsterdam (the Netherlands). The study will recruit 150 patients with metastatic castrate-resistant prostate cancer, who receive lutetium-177-PSMA treatment according to routine clinical care.  

In addition to this standard-of-care/routine care, ILLUMINATE will add metabolic-MRI to the imaging regimen as a multimodal (PET/CT and metabolic-MRI) theranostics approach. According to routine clinical care, patients will receive up to six cycles of lutetium-177-PSMA with an interval of 6-9 weeks. PSMA PET/CT will be performed at baseline and after every two cycles for response analyses. Metabolic-MRI will be performed at the same timepoints as PSMA PET/CT. 

The main goal of ILLUMINATE's clinical study is to investigate whether metabolic-MRI has predictive value to determine which patients respond to lutetium-177 treatment. Metabolic-MRI should therefore be able to discriminate between patients who are expected to have short or long survival following their cancer diagnosis. The ILLUMINATE study aims to find a (set of) biomarkers from the conducted metabolic-MRI scans which can be used in a clinical setting to improve cancer treatment efficacy. 

As mentioned, 30% of cancer patients do not respond to lutetium-177 treatment but still experience the associated side effects that impact their quality of life. The biomarkers obtained from the ILLUMINATE clinical study could prevent these patients from having to undergo an invasive treatment without benefitting from it.