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RECRUITING
NCT06071195

All-in-One Prostate Cancer Staging with MRI

Sponsor: European Institute of Oncology

View on ClinicalTrials.gov

Summary

Prior to treatment, it is essential to assess not only the extent of prostate cancer within the prostate, but also to determine whether the disease has initiated metastatic spread. Whole-body MRI has become a viable option for the detection of metastatic disease derived from a number of cancers, but is typically performed in a separate scanning session to an initial dedicated prostate MRI in which the local disease is assessed. In patients known to be at high risk for significant prostate cancer prior to this initial MRI, and thus highly likely to proceed to treatment, this delays arriving at a definitive treatment decision. The investigators will evaluate the sensitivity of a protocol that combines bi-parametric prostate MRI, performed according to PI-RADS v2.1 guidelines, with a whole-body MRI based on the METastasis Reporting and Data System for Prostate Cancer (MET-RADS-P) guidelines, for an All-in-One, local and systemic staging of intermediate-favorable or high risk prostate cancer patients. The resulting staging decisions will be compared to the results of systemic staging with those obtained by computed tomography and bone scintigraphy in the standard staging pathway.

Key Details

Gender

MALE

Age Range

35 Years - Any

Study Type

OBSERVATIONAL

Enrollment

400

Start Date

2021-12-22

Completion Date

2026-08-22

Last Updated

2024-09-27

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

Prostate Cancer Patients

see arm/group description

Locations (3)

Spedali Civili di Brescia

Brescia, BS, Italy

Istituto Europeo di Oncologia

Milan, MI, Italy

Azienda Ospedaliera Universitaria Integrata di Verona, Ospedale Borgo Roma

Verona, VR, Italy