Prostate Cancer Screening: a Pilot Study — ProScreenMRI  

Prostate Cancer Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT06238661
• Study type: Interventional
• Source: Fondazione del Piemonte per l'Oncologia
• Contact: Daniele Regge, MD
• Phone: +390119933021
• Email: daniele.regge@ircc.it
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Completion date: July 1, 2025