Prostate cancer, Lu-177-PSMA treatment, response Prostate cancer, treatment response
Conditions
Interventions
MeMRI examinations at ultra-high magnetic field strength to  
investigate the predictive value of MeMRI 
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Eligible for PSMA-targeted 177Lu radioligand therapy according to the European Public Assessment Report (EPAR) of the EMA for 177Lu-vipivotide tetraxetan (Pluvicto®) EMA/825883/2022.At least one metastasis that can be reliably assessed with MRI (location not restricted).ECOG performance score 0-1.Patient is suitable for 7 T MRI examination (no contraindications to ultra-high-field MRI).
Exclusion criteria
Exclusion criteria: Contraindications to 7 T MRI (e.g. non-MRI–compatible implants, severe claustrophobia, or other safety concerns).Any other condition precluding safe administration of 177Lu-PSMA radioligand therapy according to EMA SmPC/EPAR.The presence of diabetes mellitus type 1 or 2 with antidiabetic medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main independent variables are the values of cell proliferation and energy metabolism biomarkers at the first on-treatment MeMRI (i.e., after every two cycles of Lu-177-PSMA). The cell proliferation biomarker is defined as the ratio of phospho-mono-esters to phospho-di-esters (PME/PDE) of the on-treatment MeMRI. When more than one metastasis is found, the max. ratio across metastases with a volume of at least 2 cm3 will be used. The energy metabolism biomarker is defined as the ratio of the increase in lactate level of the last relative to the first scan of the on-treatment MRI session to the relative increase at baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Predicted probability of overall survival at prespecified time horizons (e.g., 6, 12, 18 months) based on features measured at first on-treatment MeMRI (at second cycle of therapy), combined with available baseline and on-treatment imaging (PSMA-PET/CT), laboratory and clinical characteristics. | — |
Countries
Netherlands
Contacts
Public ContactS. Kalaykhan
Universitair Medisch Centrum Utrecht
Outcome results
None listed