Two MRI scans better than one for prostate cancer detection?
NCT ID NCT07355504
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new way to detect prostate cancer early by looking at changes in MRI scans over time instead of relying on a single scan. About 380 men with suspicious MRI findings will be followed to see if this approach reduces unnecessary biopsies and over-treatment. The goal is to catch only the cancers that truly need treatment.
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 380 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2033
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: * Men aged over 18 years * Men with an estimated life expectancy of more than 10 years * Biopsy-naïve men * PSA level ≤ 20 ng/ml * Presence, on the first multiparametric prostate MRI, of a PIRADS 3-5 lesion confirmed by local rereading if the MRI was performed outside the center * MRI of sufficient quality (PI-QUAL score 2-3) * PIRADS 3 lesion with a PSA density \<0.15 ng/ml/ml * No signs of extracapsular extension or seminal vesicle invasion (MRI stage T2 confirmed by local rereading if MRI performed outside the center) * No suspicious lymph node (confirmed by local rereading if MRI performed outside the center) * Patient is insured (affiliated with the national health insurance system or benefiting from such coverage) * Signed informed consent form Exclusion Criteria: * Men already under surveillance for a known MRI lesion (except if the previous MRI was performed less than 6 months ago) * Known mutation in DNA repair genes or suggestive family history * PIRADS 3 lesion with PSA density \< 0.15 ng/ml/ml * PIRADS 5 lesion with suspected extracapsular extension or seminal vesicle invasion * Suspicion of lymph node involvement * Multiparametric prostate MRI showing a PIRADS 1-2 lesion * Use of treatments that may modify the appearance of MRI lesions: 5-alpha reductase inhibitors, hormone therapy * Patient with severe renal insufficiency (GFR \< 30 ml/min/1.73 m²) * Contraindication to gadolinium injection * Contraindication to prostate biopsy * Vulnerable persons (covered by Articles L1111-6 to L1111-8 of the French Public Health Code)
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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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university Hospital Grenoble
Grenoble, Grenoble, 38043, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?