Prostate Cancer Screening: a Pilot Study (NCT06238661) | Clinical Trial Compass
By InvitationNot Applicable
Prostate Cancer Screening: a Pilot Study
Italy4,500 participantsStarted 2025-02-17
Plain-language summary
Prostate Cancer (PCa) is the second most frequently diagnosed tumour and the third most lethal among men in Europe. The lack of precise tools and examinations to precisely diagnose PCa has caused overtreatment of indolent and low-aggressive PCa, while in some other cases, with aggressive disease, diagnosis and treatment are dangerously delayed because cancer could be potentially missed. The present trial aims to study a new pathway to early diagnose PCa with Magnetic Resonance Imaging (MRI) to identify men who will not need treatment and those who will benefit from radical treatment, thus improving disease control and quality of life.
Who can participate
Age range
55 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* age between 55-65 years;
* asymptomatic or paucisymptomatic from a urological point of view;
* no previous prostate biopsy;
* living in the ASL TO5 (Piedmont, Italy);
* signed written informed consent.
Exclusion Criteria:
* positive oncologic anamnesis for prostate cancer;
* previous biopsy or prostate surgery;
* previous radiotherapy of the pelvis;
* any contraindication to MRI examination;
* claustrophobic or uncollaborative subjects.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Detection rate of clinically significant prostate cancer (Gleason Group ≥2)
Timeframe: 24 months
2
Comparison of the detection rate of clinically significant prostate cancer with and without screening
Timeframe: 24 months
3
Verify that the detection rate of clinically significant prostate cancer with the screening strategy is not inferior to that of the Italian cohort in the ERSPC study