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Incidence of significant prostate cancer after negative MRI and systematic biopsy in the FUTURE trial

  • Leonie Exterkate 1,
  • Olivier Wegelin 2,
  • Jelle O. Barentsz 3,
  • Marloes G. Van Der Leest 3,
  • J. Alain Kummer 4,
  • Willem Vreuls 5,
  • Peter C. De Bruin 5,
  • J. Alfred Witjes 6,
  • Harm H.E. Van Melick 2,
  • Diederik M. Somford 1
1 Department of Urology, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands 2 Department of Urology, St. Antonius Hospital, Nieuwegein, /Utrecht, The Netherlands 3 Department of Radiology and Nuclear Medicine, Radboudumc Nijmegen, The Netherlands 4 Department of Pathology, St. Antonius Hospital, Nieuwegein, /Utrecht, The Netherlands 5 Department of Pathology, Canisius-Wilhelmina Hospital, Nijmegen, The Netherlands 6 Department of Urology, Radboudumc Nijmegen, The Netherlands

Publication: BJU International, August 2022


There is no standard follow-up protocol for men with a negative evaluation with systematic biopsies (SB) and multiparametric (mp)MRI and a persistent clinical suspicion of prostate cancer (PCa). Unnecessary follow-up could lead to potentially harmful diagnostic procedures, overdiagnosis and overtreatment of insignificant (ns)PCa.


To assess the proportion of clinically significant (cs)PCa during follow-up after negative SB followed by non-suspicious mpMRI and persistent clinical suspicion of PCa compared to the general population.

Patients and Methods

A prospective study including a subgroup of patients from a multicenter randomised controlled trial conducted between 2014-2017 including 665 men with prior negative SB with a persistent elevated prostate-specific antigen (PSA) and/or suspicious digital rectal examination (DRE) undergoing mpMRI.
All patients with negative SB and PI-RADS≤2 on mpMRI entered biochemical follow-up. Follow-up until December 2021 was collected by reviewing institutional hospital records and the Dutch Pathology Registry (PALGA).
Primary outcome was the observed number of csPCa (Gleason≥3+4/ISUP grade group (GG)≥2) cases during follow-up compared to the expected number in the general population (standardised incidence ratio, SIR).


In total, 431 patients had non-suspicious mpMRI and entered biochemical follow-up. After a median follow-up of 41 months (IQR 23-57) 38 patients were diagnosed with PCa of whom 13 (3.0%) had csPCa. SIR for csPCa was 4.3 (95%-CI 2.3-7.4) (total excess of eight cases). A higher risk of a positive biopsy for (cs)PCa based on the European Randomized Study of Screening for Prostate Cancer (ERSPC)-risk calculator and a suspicious repeat MRI (PI-RADS≥3) were significant predictive factors for csPCa.


Following negative prior biopsy and non-suspicious mpMRI the risk of csPCa is low. However, compared to the general population the risk of csPCa is increased despite the high negative predictive value (NPV) of mpMRI. More research focusing on biochemical and image-guided risk-adapted diagnostic surveillance strategies is warranted.