All-in-One Prostate Cancer Staging with MRI

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.

NCT Number	NCT06071195
Lead Sponsor	European Institute of Oncology Collaborators: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Azienda Ospedaliera Universitaria Integrata Verona
Conditions	Prostate Cancer
Enrollment	400 participants
Start Date	2021-12-22
Primary Completion	2026-06-22 (estimated)
Study Completion	2026-08-22 (estimated)
Updated on ClinicalTrials.gov	2024-09-27