Virtual biopsy: a painless MRI scan that spots aggressive prostate cancer
NCT ID NCT04420702
First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time
Summary
This study tests whether a new type of MRI scan, called Diffusion Basis Spectrum Imaging (DBSI), can accurately detect clinically significant prostate cancer without the need for a needle biopsy. Researchers will compare DBSI results to standard biopsy findings in 500 men — some with suspected cancer and others already on active surveillance. If DBSI proves reliable, it could offer a non-invasive, faster, and more comfortable way to diagnose dangerous prostate cancers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MRI with DBSI analysis
- What this could lead to
- If successful, this could replace many invasive prostate biopsies with a quick, painless MRI scan, enabling earlier and more accurate detection of dangerous cancers.
- What could go wrong
- This is a relatively early study comparing DBSI to standard biopsy; the imaging technique may not be accurate enough in all patients, and results need validation in larger, diverse populations.
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 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2020
- Expected to finish
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May 2027
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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18 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.
Show the full entry requirements Hide 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: * Over 18 years of age and willing and able to provide informed consent. * Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care ("early detection cohort") * Including those men with: * an elevated PSA and no prior biopsy * an elevated PSA and a negative prior biopsy * Patients with a prior diagnosis of prostate cancer, who are currently managed with active surveillance, who are planning to undergo biopsy as clinical standard of care ("active surveillance cohort") Exclusion Criteria: * Patients with any clinical contraindication to MRI \*Including but not limited to: * Those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators * Those with cochlear implants * Those with claustrophobia not relieved with medications (patients with claustrophobia who do not need medications for the scan or whose claustrophobia can be managed with medication, are eligible to participate) * Those who cannot lie flat for over 1 hour * Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation)
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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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Washington University School of Medicine
RECRUITINGSt Louis, Missouri, 63110, United States
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