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 it reduce unnecessary biopsies and overtreatment?
Eligibility criteria
Qualifiers
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
Disqualifiers
Men who have previously undergone a prostate biopsy
Men who have a prior PCa diagnosis
using any (anti-)hormonal therapy, including 5-alpha-reductase inhibitors
Proven germline mutation for PCa (for example: BRCA1; BRCA2)
Trial design
Treatments tested in this trial
- PSA and MRI-monitoring