All-in-One Prostate Cancer Staging with MRI
This study is testing if using a special type of MRI can help doctors better understand the stage of prostate cancer in patients at high risk, all in one visit.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 35 Years and up |
| Sex | Male |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Brescia, BS and 2 other locations) |
| Trial ID | NCT06071195 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of combining bi-parametric prostate MRI with whole-body MRI to assess both local and metastatic prostate cancer in a single session. The goal is to improve the accuracy of staging for patients at high risk of significant prostate cancer, which can expedite treatment decisions. By adhering to established guidelines for imaging, the study aims to determine the sensitivity of this combined approach compared to traditional methods. The research is particularly focused on patients who are eligible for active treatment options.
Who should consider this trial
Good fit: Ideal candidates are men diagnosed with intermediate-favorable or high-risk prostate cancer who are eligible for active treatment.
Not a fit: Patients with contraindications to MRI or those who have received prior hormone or radiation therapy for prostate cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster and more accurate treatment decisions for prostate cancer patients.
How similar studies have performed: While multi-parametric MRI is standard for local assessment, the combination with whole-body MRI for staging is a novel approach that has not been widely tested.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Brescia, BS and 2 other locations
- Spedali Civili di Brescia — Brescia, Bs, Italy (Recruiting)
- Istituto Europeo di Oncologia — Milan, Mi, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Integrata di Verona, Ospedale Borgo Roma — Verona, Vr, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Giuseppe Petralia, MD — European Institute of Oncology, IEO IRCCS
- Study coordinator: Giuseppe Petralia, MD
- Email: giuseppe.petralia@ieo.it
- Phone: +39 02 94372901
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.