NCT06238661

Prostate Cancer Screening: a Pilot Study

Prostate Cancer Screening With PSA, Risk Calculator and Multiparametric MRI: a Pilot Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,500 (estimated)
• Sponsor: Fondazione del Piemonte per l'Oncologia · Academic / Other
• Sex: Male
• Age: 55 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-02-17
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-02-02
• Last updated: 2026-03-05

Locations

1 site across 1 country: Italy