Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer
Recruiting
N/A
Interventional Study
Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 503 (estimated)
- Sponsor
- St. Antonius Hospital · Other
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Life expectancy \> 10 years
* initial PSA \< 20 ng/ml
* No signs of extracapsular disease on digital rectal examination
* Intermediate-risk category for suspicion of prostate cancer determined by MRI results and PSA density (PSAD): PI-RADS 3 or PI-RADS 4 with PSAD =\< 0.15
* M…
Contacts
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