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

Metastatic Castration Resistant Prostate Cancer (mCRPC) Clinical Trial

— WB-LuPSMA  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05208229
• Other study ID #: IRST185.08
• Status: Terminated
• Start date: October 25, 2022
• Est. completion date: October 25, 2022

Study information

• Verified date: May 2023
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: October 25, 2022
• Est. primary completion date: October 25, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Castration Resistant Prostate Cancer (mCRPC)
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST s.r.l.	Meldola	Forlì-Cesena
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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