New strategy aims to cut unneeded prostate biopsies in half
NCT ID NCT07398690
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new way to decide who needs a prostate biopsy. Instead of relying only on MRI, it adds a blood test called Prostate Health Index (PHI) to better tell which men have dangerous prostate cancer. The goal is to safely skip biopsies in men with low-risk findings, reducing pain and complications. About 1,400 men with elevated PSA will be randomly assigned to the standard or the new approach.
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
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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
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About 1,432 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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20 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male, aged 20 years or older * Serum PSA ≥3.0 ng/mL and ≤20.0 ng/mL and/or abnormal digital rectal -examination * Biopsy-naïve * Clinical stage ≤T2 disease * Ability to provide written informed consent Exclusion Criteria: * Previous prostate biopsy or prostate cancer treatment * Use of 5-alpha reductase inhibitors within 6 months * Acute prostatitis or urinary tract infection within 3 months * Contraindications to MRI * Contraindications to prostate biopsy
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Asan Medical Center
RECRUITINGSeoul, South Korea
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Other studies related to the condition(s) this trial covers.
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- A scanner in the operating room could show surgeons exactly where prostate cancer remains