GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies
NCT ID: NCT07258056
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-11-03
2038-12-31
Brief Summary
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Can biopsies safely be avoided at PRIMARY score 1-2 without missing csPCa? Does targeted PSMA PET/MRI-guided biopsies have a higher detection rate of csPCa compared to systematic biopsies?
Participants will undergo both transperineal MRI/ultrasound fusion target biopsies from PRIMARY score 3-5 lesions on PSMA PET and systematic biopsies irrespective of the PRIMARY-lesion.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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PSMA-guided and systematic biopsies
Both PSMA-guided and systematic biopsies are performed
PSMA-guided and systematic biopsies
Both PSMA-guided and systematic biopsies are performed
Interventions
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PSMA-guided and systematic biopsies
Both PSMA-guided and systematic biopsies are performed
Eligibility Criteria
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Inclusion Criteria
* Negative MRI (PI-RADS 1-2) or negative biopsy from MRI-target
* MRI within 6 months
* Read and understand danish
* Expected remaining lifetime \> 10 years
Exclusion Criteria
* MRI contraindications
18 Years
MALE
No
Sponsors
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Mads Ryo Jochumsen
OTHER
Responsible Party
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Mads Ryo Jochumsen
MD, Ph.D.
Locations
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Aarhus University Hospital
Aarhus N, Aarhus, Denmark
Goedstrup Hospital
Herning, Herning, Denmark
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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1-10-72-109-25
Identifier Type: -
Identifier Source: org_study_id
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