Prostate Cancer Screening: a Pilot Study (ProScreenMRI)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: Urology visit with Risk Calculator and MRI

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.

• Study Type: Interventional
• Enrollment (Estimated): 4500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniele Regge, MD; Phone Number: +390119933021; Email: daniele.regge@ircc.it
• Study Contact Backup: Name: Francesco Porpiglia, MD; Phone Number: +390119933912; Email: francesco.porpiglia@ircc.it

Study Locations

• Italy
  • Candiolo, Italy, 10060
    • Fondazione del Piemonte per l'Oncologia
    • Contact: Daniele Regge, MD; Phone Number: +390119933021; Email: daniele.regge@ircc.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects with PSA ≥ 3 ng/ml; Urologic examination; Risk calculation (ERSPC no.6); Magnetic resonance imaging; (optional) biopsy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection rate of clinically significant prostate cancer (Gleason Group ≥2)	No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial	24 months
Comparison of the detection rate of clinically significant prostate cancer with and without screening	No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial compared to the same proportion of men calculated in the 2-year period before the introduction of the screening protocol	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	No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial compared to the same proportion of men included in the Italian cohort of the ERSPC study screened using PSA only	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of positive and negative predictive values	Definition of positive and negative predictive values of the proposed screening strategy and comparison with those obtained in the ERSPC screening study with PSA only	24 months
Changes in number of biopsy procedures	Estimation of the number of biopsy that could be avoided using the new screening strategy compared to the use of PSA only.	24 months

Collaborators and Investigators

• Sponsor: Fondazione del Piemonte per l'Oncologia
• Collaborators: San Luigi Gonzaga Hospital; Epidemiology and Screening Unit - CPO, Turin, Italy
• Investigators: Principal Investigator: Daniele Regge, MD, Fondazione del Piemonte per l'Oncologia

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: PSA; Prostate Cancer; Magnetic Resonance Imaging; Prostate biopsy; Risk Calculator
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: ProScreenMRI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No