Prostate CancerProScreenMRINCT06238661
Prostate Cancer Screening: a Pilot Study
A study testing Urology visit with Risk Calculator and MRI in people with Prostate Cancer, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 55 to 65 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Urology visit with Risk Calculator and MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,500 participants
- Where
- 1 siteItaly
- Study dates
- 17 Feb 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Being tested
- Urology visit with Risk Calculator and MRI
- Keywords
- Prostate Cancer, PSA, Risk Calculator, Magnetic Resonance Imaging, Prostate biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Subjects with PSA ≥ 3 ng/ml | Experimental | * Urologic examination
* Risk calculation (ERSPC no.6)
* Magnetic resonance imaging
* (optional) biopsy Receives: Diagnostic Test: Urology visit with Risk Calculator and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 24 months
Secondary outcomes (2)
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.
Measured: 24 months
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start17 Feb 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Collaborators
- San Luigi Gonzaga Hospital, Epidemiology and Screening Unit - CPO, Turin, Italy, ASL TO5
- Responsible party
- Sponsor
- Investigators
- Daniele Regge, MD, Principal investigator, Fondazione del Piemonte per l'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238661
- Sponsor's protocol ID
- ProScreenMRI
- Acronym
- ProScreenMRI
- Status last verified
- Mar 2026
- First submitted
- 25 Jan 2024
- Last updated
- 5 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Screening With PSA, Risk Calculator and Multiparametric MRI: a Pilot Study
- ClinicalTrials.gov ID
- NCT06238661
- Acronym / sponsor ID
- ProScreenMRI / ProScreenMRI
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, PSA, Risk Calculator, Magnetic Resonance Imaging, Prostate biopsy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Collaborators
- San Luigi Gonzaga Hospital, Epidemiology and Screening Unit - CPO, Turin, Italy, ASL TO5
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with PSA ≥ 3 ng/ml | Experimental | Diagnostic Test: Urology visit with Risk Calculator and MRI* Urologic examination * Risk calculation (ERSPC no.6) * Magnetic resonance imaging * (optional) biopsy |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urology visit with Risk Calculator and MRIPatients with PSA ≥3 ng/ml will undergo urology visit with risk calculator and MRI assessment of the prostate | Diagnostic test | Subjects with PSA ≥ 3 ng/ml |
Primary outcome
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
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
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
2 secondary outcomes
Changes in number of biopsy procedures
Time frame: 24 months
Assessment of positive and negative predictive values
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniele Regge, MD principal investigator
Fondazione del Piemonte per l'Oncologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urology visit with Risk Calculator and MRI in people with Prostate Cancer, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of clinically significant prostate cancer (Gleason Group ≥2) (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.