Detection Rate of Prostate Cancer in Men Undergoing MRI
NCT ID: NCT04398173
Last Updated: 2021-04-14
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
400 participants
OBSERVATIONAL
2014-11-01
2020-12-31
Brief Summary
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Secondary objective will be to compute the negative predictive value of MRI in subject with no lesion detected at imaging or no cancer confirmed at biopsy, considering a follow-up of at least 2 years.
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Detailed Description
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To reach primary aim, men with positive MRI (clinically significant lesions with PI-RADS score \>= 3) and biopsy data will be considered.
In men with negative MRI (clinically insignificant lesions or regions classified as PI-RADS 2 at MRI), follow-up with PSA data and repeated MRI and/or biopsy will be considered.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Group A (previous negative biopsy)
Men with clinical suspicion of PCa, previous negative prostate biopsy who underwent prostate MRI
multiparametric MRI
T1-w, T2-w, diffusion weighted and dynamic contrast-enhanced imaging
Group B (biopsy naive)
Men with clinical suspicion of PCa, no previous negative prostate biopsy who underwent prostate MRI
multiparametric MRI
T1-w, T2-w, diffusion weighted and dynamic contrast-enhanced imaging
Interventions
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multiparametric MRI
T1-w, T2-w, diffusion weighted and dynamic contrast-enhanced imaging
Eligibility Criteria
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Inclusion Criteria
* PSA values persistently greater than 4 ng/ml
* multiparametric MRI of the prostate between nov-2014 and nov-2016
* MRI with endorectal coil
Exclusion Criteria
50 Years
MALE
No
Sponsors
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Fondazione del Piemonte per l'Oncologia
OTHER
Responsible Party
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Locations
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Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute
Candiolo, Turin, Italy
Countries
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Other Identifiers
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ProBiopsy-RM19
Identifier Type: -
Identifier Source: org_study_id
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