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The study was linked to another protocol that is over
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with mCRPC enrolled in the Tumor Institute of Romagna (IRST) 185.03 Lu-PSMA protocol | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WB-MRI | Diagnostic Test | 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 |
| 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 |
| 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. |
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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:
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Patients with mCRPC enrolled in the IRST185.03 Lu-PSMA study
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Paganelli, MD | IRST IRCCS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST s.r.l. | Meldola | Forlì-Cesena | 47014 | Italy | ||
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|
| 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 |
| European Institute of Oncology |
| Milan |
| Italy |