RecruitingNCT06071195

All-in-One Prostate Cancer Staging with MRI


Sponsor

European Institute of Oncology

Enrollment

400 participants

Start Date

Dec 22, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a single whole-body MRI scan can replace multiple separate imaging tests for staging high-risk prostate cancer — helping doctors see in one scan whether the cancer has spread. The goal is to make staging faster and more convenient for patients. **You may be eligible if...** - You have high-risk prostate cancer (high Gleason score, high PSA, or a tumor that extends beyond the prostate) - You are eligible for active treatment (surgery or radiation) and/or hormone therapy - You have a life expectancy of at least 10 years - You have signed informed consent **You may NOT be eligible if...** - You cannot have an MRI (e.g., severe claustrophobia or an MRI-unsafe implant) - You have already had treatment for prostate cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTProstate 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

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NCT06071195


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