Active surveillance in a cohort of men with prostate cancer; McGill University experience

Introduction: Active surveillance (AS) is commonly recommended for men with localized low-intermediate–risk prostate cancer (PCa). The aims of our study were to evaluate clinical and pathological factors that influence the risk for disease progression in a cohort of patients with low-intermediate risk PCa under AS and to assess the probability that patients with PCa would develop unfavorable disease features (UDF) while under AS for the purpose of evaluating whether immediate hemiablation therapy (HAT) could bring clinical benefit to selected patients.Methods: We studied a total of 300 patients diagnosed between 1992 and 2012 with prostate adenocarcinoma with favorable parameters or who refused treatment and were managed with AS. Of those, 155 patients with at least 1 repeat biopsy and no progression criteria at the time of the diagnosis were included for statistical analyses. Patients were followed every 3–6 months for prostate-specific antigen (PSA) measurement and physical examination (PE). Patients were offered repeat prostatic biopsy every year. Disease progression was defined as the presence of one or more of the following criteria: ≥3 positive cores, >50% of cancer in at least 1 core, and a predominant Gleason pattern of ≥4. In our cohort of AS patients, 157 were diagnosed with unilateral PCa with ≥1 repeated biopsy. Using five different definitions of UDF, patients' data were used to simulate the theoretical outcome if these patients were managed by immediate unilateral HAT or remained on AS. Results: For the 155 patients, the mean age (SD) at diagnosis was 67 (7) years; median follow-up was 5.4 years (interquartile range [IQR], 3.6–9.5 years). Of these, 67 patients, 25 patients, 6 patients, and 2 patients had 2, 3, 4, and 5 repeat biopsies, respectively. At baseline, 11 (7%) patients had a Gleason score (GS) of 3+4, while the remaining 144 (93%) patients had a GS of ≤6. A total of 50 (32.3%) patients showed disease progression on repeat biopsies, with a median progression-free survival time of 7 years. The rate of disease progression decreased after the second repeat biopsy. The 5-year overall survival rate was 100%. Having a PSA density (PSAD) of >0.15, >1 positive core, and GS >6 at the time of the diagnosis was associated with a significantly higher rate of disease progression on univariate analysis (P<0.05), while a maximum percentage of cancer in any core of >10% showed a trend toward significance for a higher progression rate (P=0.054). On multivariate analysis, only the presence of PSAD>0.15 remained significant for a higher progression rate (P<0.05). Of 155 patients, 5 (3.2%) subsequently received radiotherapy, 13 (8.4%) received hormonal therapy, and 13 (8.4%) underwent radical prostatectomy. Of the 157 patients who had unilateral PCa, 144 (92%) had a Gleason score (GS) of ≤6. Using the whole range of definition for UDF, 10 to 47% of patients developed UDF while under AS. Using baseline GS, maximum percentage of cancer on any core, and PSAD, we found significant trends for higher development of UDF for patients under AS. Conclusion: AS is a suitable management option for patients with clinically low-risk PCa. A PSAD of >0.15 ng/ml/cc is an important predictor for disease progression. The majority of our patients did not develop UDF while under AS and our study thus suggests that careful patient selection for focal therapy should be performed to avoid subjecting patients to unnecessary treatment.

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