NCT05208229

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2 (actual)
• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Castration Resistant Prostate Cancer (mCRPC)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-01
• Primary completion: 2022-03-08
• Completion: 2022-03-08
• First posted: 2022-01-26
• Last updated: 2025-04-01

Locations

2 sites across 1 country: Italy