Table 1

Triggers for re-biopsies

Arm 1Arm 2
According to current practice
(the urologists’ judgement)
IPSA density >0.2 ng/mL/cc (systematic biopsies)
II MRI progression in men with ISUP grade 1 cancer (targeted biopsies)
  • ≥5 mm or more increase in size in any dimension of a measurable lesion (a measurable lesion is defined as ≥6 mm in longest diameter in any dimension in best-depicted MR sequence)

  • Increase in PI-RADS score to 3, 4 or 5

  • High suspicion of extracapsular extension or seminal vesicle invasion (level of suspicion to be 4 or 5 on Likert scale)

  • A new lesion with PI-RADS score 3–5

III MRI progression in men with ISUP grade 2 cancer (targeted biopsies)
  • ≥5 mm or more increase in size in any dimension of a measurable lesion (a measurable lesion is defined as ≥6 mm in longest diameter in any dimension in best-depicted MR sequence)

  • A new lesion with PI-RADS 3–5

  • ISUP, International Society of Urological Pathology; PI-RADS, Prostate Imaging Reporting and Data System; PSA, prostate-specific antigen.