Fewer biopsy cores may be safer and just as accurate for prostate cancer detection

NCT ID NCT04183699

Diagnosis Sponsor: IRCCS San Raffaele Source: ClinicalTrials.gov ↗

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

Summary

This study looked at whether taking fewer systematic biopsy cores (6 instead of 20) during an MRI-targeted prostate biopsy could still detect dangerous prostate cancers while reducing risks like infection and overdiagnosis. The trial involved 126 men with suspicious MRI results. It was terminated early, so the findings are limited.

What this could mean

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

What this could lead to: If successful, this could help doctors use fewer biopsy cores during MRI-targeted prostate biopsies, reducing infection risk and overdiagnosis while still catching dangerous cancers.
What could go wrong: The trial was terminated early, so results may be incomplete. The approach may not work for all patients or may miss some cancers.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

126 people

The number who actually took part.

Started

Jun 2019

Finished

Jun 2026

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.

Ages

18 to 80 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: * Male patients, aged between 18 and 80 years old with suspicion of prostate cancer * Presence of a positive mpMRI of the prostate (visible lesion PI-RADS ≥ 3) * Serum PSA ≤ 20ng/ml * Suspected stage ≤ T2 on rectal examination (organ confined prostate) * Fit to undergo a prostate biopsy * Able to understand and willing to sign a written informed consent document Exclusion Criteria: * Prior positive prostate biopsy * Prior treatment of the prostate * Prostate volume \<30 ml at mpMRI of the prostate * More than one lesion at mpMRI of the prostate * Contraindication to prostate biopsy

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

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

Suspicion of prostate cancer with A positive multiparametric magnetic resonance of the prostate

Fewer biopsy cores may be safer and just as accurate for prostate cancer detection

What the study statuses mean