Metastatic Castration Resistant Prostate Cancer (mCRPC)
Conditions
Keywords
WB-MRI (Whole Body- Magnetic Resonance Imaging), 177Lu-PSMA 617, metastatic Castration Resistant Prostate Cancer (mCRPC), Radio Metabolic Therapy (RMT)
Brief summary
The role of WB-MRI in the evaluation of prostate cancer patients treated with Lu-PSMA
Detailed description
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.
Interventions
DIAGNOSTIC_TESTWB-MRI
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
Sponsors
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease progression | up to 42 months | To evaluate whether WB-MRI allows earlier identification of disease progression in comparison to CT in mCRPC patients based on imaging criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility of The Metastasis (MET) Reporting And Data System (RADS) for Prostate Cancer (P) (MET - RADS - P) assessment of WB-MRI | up to 42 months | 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. |
| response with WB-MRI compared to other assessment | up to 42 months | 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. |
Countries
Italy
Outcome results
None listed