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Gene test could revolutionize prostate cancer screening

NCT ID NCT07265414

Diagnosis Sponsor: Istituto Clinico Humanitas Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether men with certain gene mutations (DRG) could benefit from a more tailored screening for prostate cancer. Researchers will test a combination of a blood test (PHI) and a special MRI scan in 320 men with or at risk for prostate cancer. The goal is to see if this approach finds cancers earlier and more accurately than the current PSA test and digital rectal exam.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Screening platform combining PHI blood test and mp-MRI scan
What this could lead to
If successful, this could lead to a more effective, personalized screening approach for men with DRG mutations, catching prostate cancer earlier and reducing both overdiagnosis and missed cases.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve outcomes. The approach may not prove better than standard screening, and results may not apply to all men.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

320 people

The number who actually took part.

Started

Jan 2021

Expected to finish

Jan 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

* Contraindication absolute or relative to mpMRI * Active perineal/pelvic inflammatory disease * Urethral stricture or previous surgery for urethral surgery. * Subjects with chronic renal failure, marked blood protein alterations (plasma normal range 6-8 g/100 mL), hemophiliacs, or those previously submitted to multiple blood transfusions were not included in the study, as these conditions may alter the PHI analysis. * Any other condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results

Ages

35 to 70 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- The following men will be screened for DRG mutations. 1. Males between the ages of 35 and 75 suffering from prostate cancer diagnosis with GS (Gleason Score) ≥ 4+3 willing to undergo screening for a mutation in one of the DNA repair genes (DRG); 2. Males under the age of 50 suffering from prostate cancer diagnosis with GS ≥ 3 +3 willing to undergo screening for a DRG mutation; 3. Consanguineous of males who, as a result of prostate biopsy and/or radical prostatectomy, have been diagnosed with prostate cancer with GS ≥ 4 + 3 and positive for a DRG mutation; 4. Consanguineous of males who following a prostate biopsy and/or radical prostatectomy had a diagnosis of prostatic cancer before the age of 50 with GS ≥ 3 +3 and positive for a DRG mutation. 5. Males and females older 18 yrs presenting with primary or secondary BC willing to undergo screening for a mutation in one of the DNA repair genes (DRG); 6. Males consanguineous of males and females who had a diagnosis of bladder cancer and positive for a DRG mutation 7. Males between the ages of 35 and 75 belonging to a family where a BRCA1/2 and/or DRG mutations has already been detected in at least one female (this screening has been and will be performed according to the AIOM 2019/NCCN 2019 guidelines, as for good clinical practice in our oncology center) Exclusion Criteria: \-

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Conditions

The condition(s) this trial relates to.

prostate cancer urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder cancer Prostate cancer

Contacts and locations

Locations

  • IRCCS Humanitas Research Hospital

    Milan, 20089, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.