The role of WB-MRI in the evaluation of prostate cancer patients treated with Lu-PSMA
Multicentric, observational, single arm, prospective, study. All patients will undergo imaging assessments according to clinical practice or to Lu-PSMA Tumor Institute of Romagna (IRST) 185.03 protocol, as follows: * Baseline, before the treatment with Lu-PSMA, CT and WB-MRI will be performed * At the end of treatment with Lu-PSMA, CT and WB-MRI will be performed * In post-treatment follow-up every 4 months, until progression or for 1 year, CT and WB-MRI will be performed. Patients participating in this observational study will not be subjected to any additional procedure that falls outside the clinical practice or the study 185.03 Lu-PSMA trial at IRST.
Study Type
OBSERVATIONAL
Enrollment
2
Baseline CT scan (minimum thorax/abdomen/pelvis) and WB-MRI evaluations will be collected: as per clinical practice and Tumor Institute of Romagna (IRST) 185.03 Lu-PSMA protocol, the assessments must not be performed more than 12 weeks prior to study entry and baseline WB-MRI should be performed within 2 weeks from CT scan; CT and WB-MRI will be done at the end of Lutetium 177 PSMA (177Lu-PSMA) therapy and during post-treatment follow-up
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST s.r.l.
Meldola, Forlì-Cesena, Italy
European Institute of Oncology
Milan, Italy
disease progression
To evaluate whether WB-MRI allows earlier identification of disease progression in comparison to CT in mCRPC patients based on imaging criteria.
Time frame: up to 42 months
Reproducibility of The Metastasis (MET) Reporting And Data System (RADS) for Prostate Cancer (P) (MET - RADS - P) assessment of WB-MRI
To assess reproducibility of MET-RADS-P assessment of WB-MRI in metastatic prostate disease. The reproducibility of MET-RADS-P assessment of WB-MRI in metastatic prostate disease will be assessed using the concordance of the Response Assessment Categories (RAC) scores (RACs) assigned by two independent observers.
Time frame: up to 42 months
response with WB-MRI compared to other assessment
Quantitative metrics describing patterns of response that can be observed on WB-MRI, on CT, and possibly on Ga PSMA Positron Emission Tomography (PET)/CT.
Time frame: up to 42 months
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