Patients with advanced metastatic prostate cancer (AMPC) can be treated with Lutetium (Lu)-177-PSMA, which extends their survival by several months. However, some patients benefit more than others, and some only suffer from side effects. Currently, we cannot tell upfront nor during treatment who will benefit.
Moreover, the treatment itself is at risk of insufficient supply due to its popularity and sensitivities in its manufacturing line.
ILLUMINATE is set up to improve availability and use of theranostics across the complete value chain. It aims to:
Develop innovative theranostic solutions by updating Metabolic MRI (MeMRI) components and technologies for application as Clinical Investigational Device (WP1). These will be validated in an observational clinical trial with Lu-177-PSMA in patients with AMPC to demonstrate the added value of MeMRI (WP3).
This new imaging biomarker aims acts as an additional triage tool. The biomarker will be designed via the use of 31P and 2H magnetic resonance spectroscopic imaging, which will provide metabolic images (MeMRI) that reflect cell proliferation and inefficient energy metabolism. The most sensitive MRI systems (7T) will be updated so that they can optimally detect metabolites in the human body. A scan protocol will be realized that it is tolerable for patients, and tested in a clinical trial (WP3).
Develop quantification & decision-making models, and broadly applicable MeMRI decision making tools (WP1). This will aid in a) personalizing the treatment and disease management of patients, and b) reducing the required supply of radioisotopes based on improved patient stratification, dosing, and cessation of treatment.
Broaden the availability of MeMRI technology by facilitating its application across different platforms (WP2). Easier to scale MeMRI technology will be prepared and made available to the wider clinical society (for widely available clinical 1.5T MRI) by making use of a technology called chemical exchange by saturation transfer (CEST). This technology requires a contrast agent and subtle upgrades to 1.5T MRI systems.
Improve manufacturing capability by increasing capacity of Lu-177 production, development of a recycling process for the starting material Ytterbium, and by developing expertise on centralized preparation of Lu-177 radiopharmaceuticals (WP2). This approach aims to make the supply chain of Lu-177 more robust and make Lu-177 more widely available in the EU.
Investigate and develop relevant rules, regulations and policies to improve access to the developed technologies (WP4). A guideline for in-house manufacturing of metabolic profiling on a 7T MR scanner will be developed. A regulatory strategy will be developed for radionuclide-based theranostics. We also aim to investigate Lu treatment policies in different EU countries. This can inform policy making, and might provide new opportunities to reduce healthcare costs, increase patient satisfaction, and make the treatment wider available.
Ensure stakeholder engagement by developing and executing a patient engagement plan and by establishing a stakeholder involvement community (STIC),, and collect health care professional experiences, increasing chances for sustainable outcome implementation of outcome and follow-up beyond the project (WP5).
Develop training materials for (medical) professionals based on the developed solutions, and disseminate these through workshops, conferences and training and integration into educational programmes (WP5).
Communicate and disseminate the results and overall progress to a wide audience. Provide excellent project & partnership management to steer the consortium towards success.
