Prostate Cancer Screening: a Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Urology visit with Risk Calculator and MRI.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 55 years — 65 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prostate Cancer Screening With PSA, Risk Calculator and Multiparametric MRI: a Pilot Study
Overview
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.
Detailed description
Men aged 55-65 years with neither previous biopsy nor prostate diseases will be invited in the screening protocol and will perform an initial PSA test. Those cases with PSA ≥ 3 ng/ml will be invited to undergo a urologic examination with computed risk assessment and an MRI, which is a non-invasive test with high positive and negative predictive value in identifying clinically significant prostate cancer. Then, only men with medium-high risk of harbouring clinically significant prostate cancer will be invited to undergo a prostate biopsy to indentify cancer presence and its aggressiveness.
Interventions
- Diagnostic test Urology visit with Risk Calculator and MRI
Patients with PSA ≥3 ng/ml will undergo urology visit with risk calculator and MRI assessment of the prostate
Primary outcome measures
- Detection rate of clinically significant prostate cancer (Gleason Group ≥2) [Time frame: 24 months]
- Comparison of the detection rate of clinically significant prostate cancer with and without screening [Time frame: 24 months]
- 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 [Time frame: 24 months]
Secondary outcome measures (2)
- Changes in number of biopsy procedures [Time frame: 24 months]
- Assessment of positive and negative predictive values [Time frame: 24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Italy · 1 center
- Fondazione del Piemonte per l'Oncologia — Candiolo
Identifiers
NCT: NCT06238661 · ProScreenMRI