The Role of WB-MRI in the Evaluation of Prostate Cancer Patients Treated With Lutetium - Prostate Specific Membrane Antigen (Lu-PSMA)

Study Overview
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Brief Summary
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The role of WB-MRI in the evaluation of prostate cancer patients treated with Lu-PSMA

Detailed Description
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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.

Official Title
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The Role of WB-MRI in the Evaluation of Prostate Cancer Patients Treated With Lu-PSMA

Conditions
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Metastatic Castration Resistant Prostate Cancer (mCRPC)

Intervention / Treatment
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* Diagnostic Test: WB-MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients with mCRPC enrolled in the Tumor Institute of Romagna (IRST) 185.03 Lu-PSMA protocol, performing baseline CT and WB-MRI examinations and at least one CT and WB-MRI re-evaluation. Exclusion Criteria: no exclusion criteria
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with mCRPC enrolled in the Tumor Institute of Romagna (IRST) 185.03 Lu-PSMA protocol<br>Patients with mCRPC enrolled in the IRST 185.03 Lu-PSMA study, performing baseline CT and WB-MRI examinations and at least one CT and WB-MRI re-evaluation. | Diagnostic Test: WB-MRI<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease progression | To evaluate whether WB-MRI allows earlier identification of disease progression in comparison to CT in mCRPC patients based on imaging criteria. | up to 42 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | up to 42 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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WB-MRI (Whole Body- Magnetic Resonance Imaging), 177Lu-PSMA 617, metastatic Castration Resistant Prostate Cancer (mCRPC), Radio Metabolic Therapy (RMT)