Overview
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
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
- Mentally competent and able to comprehend the potential benefits and burdens of the study
- Willing to undergo the follow-up protocol for a maximum of four years
- written and signed informed consent
Exclusion Criteria:
- 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)
- Secondary malignancy, besides basal cell carcinoma of the skin, for which the potential participant is receiving active treatment at the time of inclusion.
- severe claustrofobia or other conditions that make (repeat) MRI unsuitable (e.g., metal implants, pacemakers)