Prostate Cancer Screening: a Pilot Study (ProScreenMRI)

Fondazione del Piemonte per l'Oncologia

Status: Invitation-only

Conditions: Prostate Cancer

Treatments: Diagnostic Test: Urology visit with Risk Calculator and MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT06238661

ProScreenMRI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,500 estimated patients

Sex: Male

Ages: 55 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4,500 participants in 1 patient group

Subjects with PSA ≥ 3 ng/ml

Experimental group

Description:

* Urologic examination * Risk calculation (ERSPC no.6) * Magnetic resonance imaging * (optional) biopsy

Treatment:

Diagnostic Test: Urology visit with Risk Calculator and MRI