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

Terminated

• Conditions: Metastatic Castration Resistant Prostate Cancer (mCRPC)
• Interventions: Diagnostic Test: WB-MRI

• Registration Number: NCT05208229
• Lead Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

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.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-26
• Primary Completion: 2022-03-08
• Study Completion: 2022-03-08
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 2

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with mCRPC enrolled in the Tumor Institute of Romagna (IRST) 185.03 Lu-PSMA protocol	WB-MRI	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

European Institute of Oncology; 🇮🇹 Milan, Italy

IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST s.r.l.; 🇮🇹 Meldola, Forlì-Cesena, Italy