Detection Rate of Prostate Cancer in Men Undergoing MRI
A Retrospective Observational Study to Assess Prostate Cancer Detection Rate in Men Undergoing Magnetic Resonance Imaging: Comparison Between Subjects With Previous Negative Biopsy and Biopsy Naive Men
1 other identifier
observational
400
1 country
1
Brief Summary
To assess prostate cancer (PCa) detection rate in men undergoing magnetic resonance imaging (MRI) before planning prostate biopsy. Results will be stratified considering men with/without previous negative prostate biopsy. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 30, 2020
CompletedFirst Posted
Study publicly available on registry
May 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedApril 14, 2021
April 1, 2021
6 years
January 30, 2020
April 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PCa detection rate
Number of men with positive prostate biopsy over the number of men with a positive MRI
24 months
Secondary Outcomes (1)
Negative predictive value of MRI
24 months
Study Arms (2)
Group A (previous negative biopsy)
Men with clinical suspicion of PCa, previous negative prostate biopsy who underwent prostate MRI
Group B (biopsy naive)
Men with clinical suspicion of PCa, no previous negative prostate biopsy who underwent prostate MRI
Interventions
T1-w, T2-w, diffusion weighted and dynamic contrast-enhanced imaging
Eligibility Criteria
Men with clinical suspicion of PCa, eligible for prostate biopsy
You may qualify if:
- age 50 and life expectancy greater than 10 years
- PSA values persistently greater than 4 ng/ml
- multiparametric MRI of the prostate between nov-2014 and nov-2016
- MRI with endorectal coil
You may not qualify if:
- previous history of PCa
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione del Piemonte per l'Oncologia - Candiolo Cancer Institute
Candiolo, Turin, 10060, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2020
First Posted
May 21, 2020
Study Start
November 1, 2014
Primary Completion
October 31, 2020
Study Completion
December 31, 2020
Last Updated
April 14, 2021
Record last verified: 2021-04