All-in-One Prostate Cancer Staging with MRI

Launched by EUROPEAN INSTITUTE OF ONCOLOGY · Oct 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to better understand prostate cancer before treatment begins. The goal is to combine two types of MRI scans—one that focuses on the prostate itself and another that looks at the whole body—to see if this "All-in-One" method can help doctors make quicker and more accurate decisions about treatment. This is especially important for patients who are at high risk of having more advanced cancer, as it can speed up the process of deciding on the best treatment option.

To participate in this trial, men need to meet certain criteria. They should have a specific level of cancer severity, indicated by a Gleason score of 4+3 or higher, or other conditions such as a high PSA level. Participants must also be eligible for treatment options like surgery or radiation and have a good life expectancy of at least 10 years. Throughout the trial, participants will undergo MRI scans and will be monitored to see how well this new method works compared to traditional imaging techniques. This could ultimately lead to better staging and treatment planning for prostate cancer patients.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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;