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Keywords:

  • active surveillance;
  • low risk;
  • prostate cancer;
  • radical prostatectomy;
  • biopsy

What's known on the subject? and What does the study add?

  • Several criteria have been described to select patients with prostate cancer in active surveillance (AS) protocols; however, the risk of missing unfavourable disease remains.
  • We report the risk of misclassification using the Prostate Cancer Research International: Active Surveillance (PRIAS) study in an analysis of pathological results after radical prostatectomy. We also define predictors of favourable disease that can be used to better select patients eligible for AS, as well as risk factors associated with disease progression.

Objective

  • To identify the risk of failure of active surveillance (AS) in men who had the Prostate Cancer Research International: Active Surveillance (PRIAS) criteria and had undergone radical prostatectomy (RP), by studying as primary endpoints the risk of unfavourable disease in RP specimens (stage >T2 and/or Gleason score >6) and of biochemical progression after RP.

Patients and Methods

  • We assessed 626 patients who had the PRIAS criteria for AS defined as T1c/T2, PSA level of ≤10 ng/mL, PSA density (PSAD) of <0.2 ng/mL per mL, Gleason score of <7, and one or two positive biopsies. All patients underwent immediate RP at our department between January 1991 and December 2010.
  • Multivariate logistic regression was used to test factors correlated with the risk of unfavourable prostate cancer.
  • The risk of progression was tested using multivariate Cox regression models.
  • Biochemical recurrence-free survival (BFS) was established using the Kaplan–Meier method

Results

  • Pathological study of RP specimens showed upstaging (>T2) in 129 patients (20.6%), upgrading (Gleason score >6) in 281 (44.9%) and unfavourable disease in 312 patients (50%).
  • There was a statistically non-significant trend for BFS at P = 0.06.
  • Predictors of favourable tumours were age <65 years (P = 0.005), one vs two positive biopsies (P = 0.01) and a biopsy core number >12 (P = 0.005).
  • Preoperative factors predicting disease progression were a PSAD of >0.15 ng/mL2 (P = 0.008) and biopsy core number of ≤12 (P = 0.017).

Conclusions

  • Even with stringent AS criteria, the rate of unfavourable disease remains high.
  • Predictive factors of unfavourable disease and biochemical progression should be considered when including patients in AS protocols.