Prostate Cancer Screening: a Pilot Study

NCT ID: NCT06238661

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 4500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-17
• Study Completion Date: 2026-06-30

Brief 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.

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Subjects with PSA ≥ 3 ng/ml

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

Group Type: EXPERIMENTAL

Urology visit with Risk Calculator and MRI

Intervention Type: DIAGNOSTIC_TEST

Patients with PSA ≥3 ng/ml will undergo urology visit with risk calculator and MRI assessment of the prostate

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

San Luigi Gonzaga Hospital

OTHER

Sponsor Role: collaborator

Epidemiology and Screening Unit - CPO, Turin, Italy

UNKNOWN

Sponsor Role: collaborator

ASL TO5

UNKNOWN

Sponsor Role: collaborator

Fondazione del Piemonte per l'Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniele Regge, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione del Piemonte per l'Oncologia

Locations

Fondazione del Piemonte per l'Oncologia

Candiolo, Italy, Italy

Countries

Italy

Other Identifiers

ProScreenMRI

Identifier Type: -

Identifier Source: org_study_id