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

March 31, 2025 updated by: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy
        • European Institute of Oncology
    • Forlì-Cesena
      • Meldola, Forlì-Cesena, Italy, 47014
        • IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with mCRPC enrolled in the IRST185.03 Lu-PSMA study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: WB-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease progression
Time Frame: 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.
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
Time Frame: 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.
up to 42 months
response with WB-MRI compared to other assessment
Time Frame: 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.
up to 42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Investigators

  • Study Chair: Giovanni Paganelli, MD, Irst Irccs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

March 8, 2022

Study Completion (Actual)

March 8, 2022

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

January 12, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 1, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRST185.08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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