Actively Recruiting
Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer
Led by St. Antonius Hospital · Updated on 2025-12-04
503
Participants Needed
7
Research Sites
294 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Life expectancy greater than 10 years
- Initial PSA less than 20 ng/ml
- No signs of extracapsular disease on digital rectal examination
- Intermediate-risk prostate cancer suspicion based on MRI: PI-RADS 3 or 4 with PSA density 0.15 or less
- Mentally competent and able to understand study benefits and risks
- Willing to follow the monitoring protocol for up to four years
- Provided written and signed informed consent
You will not qualify if you...
- Previously had a prostate biopsy
- Prior diagnosis of prostate cancer
- Currently using any hormonal or anti-hormonal therapies, including 5-alpha-reductase inhibitors
- Known germline mutation for prostate cancer (e.g., BRCA1, BRCA2)
- Active treatment for another cancer besides basal cell carcinoma of the skin
- Severe claustrophobia or other conditions making MRI scans unsafe (e.g., metal implants, pacemakers)
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Treant
Emmen, Drenthe, Netherlands, 7824AA
Actively Recruiting
2
Andros Clinics
Arnhem, Gelderland, Netherlands, 6842 CV
Actively Recruiting
3
Radboud University Medical Centre
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
4
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands
Actively Recruiting
5
Antoni van Leeuwenhoek Hospital
Amsterdam, North Holland, Netherlands
Actively Recruiting
6
Maasstad Hospital
Rotterdam, South Holland, Netherlands
Not Yet Recruiting
7
St Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3435 CM
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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