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

NCT05208229 | Terminated

• 1 other identifier: IRST185.08
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Metastatic Castration Resistant Prostate Cancer (mCRPC)

Keywords

WB-MRI (Whole Body- Magnetic Resonance Imaging); 177Lu-PSMA 617; metastatic Castration Resistant Prostate Cancer (mCRPC); Radio Metabolic Therapy (RMT)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• response with WB-MRI compared to other assessment

  up to 42 months

Study Arms (1)

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

Interventions

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

Patients with mCRPC enrolled in the Tumor Institute of Romagna (IRST) 185.03 Lu-PSMA protocol

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- 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.

Sponsors & Collaborators

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

Study Sites (2)

IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST s.r.l.

Meldola, Forlì-Cesena, 47014, Italy

Location

European Institute of Oncology

Milan, Italy

Location

Study Officials

• Giovanni Paganelli, MD

  IRST IRCCS

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: January 26, 2022
• Study Start: February 1, 2021
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

IT (2)