Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer

Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer

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?

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)