Evaluation of a MRI-based Prostate Cancer Screening Program
NCT ID: NCT03749993
Last Updated: 2023-05-23
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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COMPLETED
NA
241 participants
INTERVENTIONAL
2019-01-10
2023-05-01
Brief Summary
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Detailed Description
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The indication for prostate biopsy is based solely on the results of bpMRI. In case of detection of lesions suspicious for prostate cancer ( PIRADS 3), targeted MRI-TRUS fusion biopsy with 3 biopsies per lesion will be performed. In case no lesions suspicious for PCA ( PIRADS 3) are detected, SB will performed if PSA exceeds 10ng/ml and/or DRE is suspicious for PCA.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Screening Arm
Screening
Screening
Use of bpMRI for opportunistic prostate cancer screening.
Interventions
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Screening
Use of bpMRI for opportunistic prostate cancer screening.
Eligibility Criteria
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Inclusion Criteria
* prostate biopsy naïve
* life expectancy \> 10 years
* men \> 50 years of age
* men \> 45 years of age with a family history of prostate cancer
* African-Americans \> 45 years of age
Exclusion Criteria
* life expectancy \< 10 years
* acute urinary tract infection
* NIH-CPSI score 19 (leads to initiation of urologic diagnostics and treatment)
* IPSS score 20 (leads to initiation of urologic diagnostics and treatment)
Contraindications for MRI:
* Heart pacemaker
* Artificial heart valves (some types are eligible)
* Cochlea implant
* ICD
* Metallic foreign bodies/devices/implants (neuro-stimulator, pain or insulin pump, etc.)
* Severe claustrophobia
46 Years
75 Years
MALE
Yes
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Cyrill Rentsch, MD PHD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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University Hospital Basel, Clinic of Urology
Basel, , Switzerland
Countries
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Other Identifiers
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VISIONING1
Identifier Type: -
Identifier Source: org_study_id
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