Time points of enrolment and interventions
| Enrolment (month 0) | Visit 1 (month 0) | Visit 2 (months 0–3) | Visit 3/end of study (month 36±2) | |
| Informed consent and enrolment | X | |||
| Assessment of patient history, clinical stage and PSA level | X | |||
| Blood test (PHI) | X | |||
| Multiparametric MRI | X | |||
| Targeted biopsy based on human reading of magnetic resonance images (PI-RADS V.2.1) | X | |||
| Systematic biopsy | X | |||
| Assessment of adverse events | X | X | X | |
| Assessment of 3-year follow-up | X |
PHI, Prostate Health Index; PI-RADS V.2.1, Prostate Imaging-Reporting and Data System version V.2.1; PSA, prostate-specific antigen.