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

Prostate Cancer

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

Inclusion Criteria2

at least one of: International Society of Urological Pathology Grade Group ≥ 3 (Gleason Score ≥ 4+3); cT3 initial diagnosis with any PSA level; PSA ≥ 20 ng/mL with any Gleason score;
and all the following: Signed informed consent; Patients eligible to active treatment (either radical prostatectomy or radiotherapy) and/or hormone therapy; Life expectancy ≥ 10 years;

Exclusion Criteria5

Contraindications to MRI (e.g. severe claustrophobia or MRI unsafe device);
Previous or ongoing hormone therapy or radiation therapy for prostate cancer;
Significant intercurrent morbidity that, in the judgment of the investigator, would limit compliance with study protocols;
Previous mp-MRI performed within six weeks of the outpatient visit and compliant with PI-RADS v2.1 guidelines;
Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components;