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Could a new score spare men from unnecessary prostate biopsies?

NCT ID NCT07753356

Diagnosis Sponsor: Marcelo Ruben Oliva 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 07, 2026 · Last updated Aug 07, 2026

Summary

This study is testing whether a new scoring system, called the Fusion CEMEP score, can safely guide prostate biopsy decisions. The goal is to see if men with suspected prostate cancer can skip the extra systematic biopsies and only have targeted biopsies based on MRI findings. The study will compare the detection rate of significant prostate cancer using this score-guided approach against the standard full biopsy scheme. If the score works, it could reduce unnecessary procedures and overtreatment.

What this could mean

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

Active substance
Fusion CEMEP score-guided biopsy strategy
What this could lead to
If successful, this could help many men avoid extra prostate biopsies, reducing discomfort and overtreatment while still catching significant cancers.
What could go wrong
The score is still being validated, and it may not be accurate enough to safely skip biopsies in all cases. Missing a significant cancer is a serious risk.

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

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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

Male patients evaluated at the clinic with clinical suspicion of prostate cancer undergoing MRI-targeted biopsy.

Ages

18 years and older

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: * Adult male patients with clinical suspicion of prostate cancer. * Patients scheduled to undergo multiparametric MRI-targeted prostate biopsy. * Signed informed consent. Exclusion Criteria: * Prior treatment for prostate cancer. * Contraindications to prostate biopsy or multiparametric MRI.

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Conditions

The condition(s) this trial relates to.

disease prostate cancer

As listed by the trial registrant

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

Prostate cancer Prostatic neoplasms/diagnosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Clinica Cemep

    Rio Grande, Tierra del Fuego Province, 9420, Argentina

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