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Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer
Sponsor: St. Antonius Hospital
Summary
The goal of this clinical trial is to evaluate the safety and effectiveness of a novel diagnostic strategy for prostate cancer, in which men with a moderate risk of prostate cancer are monitored using PSA and MRI instead of immediate biopsy,. The main questions it aims to answer are: * Is it safe to delay biopsy, making sure that clinical significant prostate cancers are not often missed? * Does it reduce unnecessary biopsies and overtreatment?
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
503
Start Date
2025-05-14
Completion Date
2031-01
Last Updated
2025-12-04
Healthy Volunteers
No
Conditions
Interventions
PSA and MRI-monitoring
Men with PI-RADS 3 or 4 lesions and a PSA density ≤ 0.15 ng/mL² are actively monitored with PSA testing every six months and MRI annually, instead of undergoing immediate prostate biopsy.
Locations (7)
Treant
Emmen, Drenthe, Netherlands
Andros Clinics
Arnhem, Gelderland, Netherlands
Radboud University Medical Centre
Nijmegen, Gelderland, Netherlands
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands
Antoni van Leeuwenhoek Hospital
Amsterdam, North Holland, Netherlands
Maasstad Hospital
Rotterdam, South Holland, Netherlands
St Antonius Hospital
Nieuwegein, Utrecht, Netherlands