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Enrolling by Invitation

NCT Number: NCT06238661

Prostate Cancer Screening: 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

55 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione del Piemonte per l'Oncologia

Candiolo, Italy, 10060

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Urology visit with Risk Calculator and MRI

Diagnostic Test

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

Primary outcomes

  1. Detection rate of clinically significant prostate cancer (Gleason Group ≥2)

    Time frame: 24 months

    No. of detected clinically significant prostate cancer with Gleason Group ≥ 2 over the total no. of men enrolled in the trial

  2. Comparison of the detection rate of clinically significant prostate cancer with and without screening

    Time frame: 24 months

    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

  3. 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

    Time frame: 24 months

    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

Secondary outcomes

  1. Changes in number of biopsy procedures

    Time frame: 24 months

    Estimation of the number of biopsy that could be avoided using the new screening strategy compared to the use of PSA only.

  2. Assessment of positive and negative predictive values

    Time frame: 24 months

    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

Sponsors and collaborators

Lead sponsor

Fondazione del Piemonte per l'Oncologia

Other

Collaborators

  • ASL TO5
  • Epidemiology and Screening Unit - CPO, Turin, Italy
  • San Luigi Gonzaga Hospital

Registry information

Official study title

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

Acronym: ProScreenMRI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2024
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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