NCT06238661

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,500

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
2mo left

Started Feb 2025

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2025Jun 2026

First Submitted

Initial submission to the registry

January 25, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
1 year until next milestone

Study Start

First participant enrolled

February 17, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

January 25, 2024

Last Update Submit

March 3, 2026

Conditions

Prostate Cancer

Keywords

Prostate CancerPSARisk CalculatorMagnetic Resonance ImagingProstate biopsy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Changes in number of biopsy procedures

    24 months

  • Assessment of positive and negative predictive values

    24 months

Study Arms (1)

Subjects with PSA ≥ 3 ng/ml

EXPERIMENTAL

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

Diagnostic Test: Urology visit with Risk Calculator and MRI

Interventions

Urology visit with Risk Calculator and MRIDIAGNOSTIC_TEST

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

Subjects with PSA ≥ 3 ng/ml

Eligibility Criteria

Age55 Years - 65 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione del Piemonte per l'Oncologia

Candiolo, Italy, 10060, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Daniele Regge, MD

    Fondazione del Piemonte per l'Oncologia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 2, 2024

Study Start

February 17, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Locations

IT(1)