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All-in-One Prostate Cancer Staging with MRI

NCT06071195 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-09-27

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Prostate Cancer Patients

see arm/group description

Sponsors & Collaborators

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    collaborator OTHER

  • Azienda Ospedaliera Universitaria Integrata Verona

    collaborator OTHER

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Giuseppe Petralia, MD · European Institute of Oncology, IEO IRCCS

Eligibility

Min Age
35 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-22
Primary Completion
2026-06-22
Completion
2026-08-22

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06071195 on ClinicalTrials.gov