Giorgio Gandaglia1, Guillaume Ploussard2, Hendrik Isbarn3, Nazareno Suardi1, Peter J L De Visschere4, Jurgen J Futterer5, Pirus Ghadjar6, Christophe Massard7, Piet Ost8, Prasanna Sooriakumaran9, Christian I Surcel10, Roderick C N van der Bergh11, Francesco Montorsi1, Vincenzo Ficarra12, Gianluca Giannarini1, Alberto Briganti13. 1. Unit of Urology/Division of Oncology; URI; IRCCS Ospedale San Raffaele, Milan, Italy. 2. Department of Urology, Saint-Louis Hospital, Paris, France. 3. Department of Urology, Regio Clinic Wedel, Wedel, Germany; Martini-Clinic, Prostate Cancer Center Hamburg-Eppendorf, Germany. 4. Department of Radiology, Ghent University Hospital, Ghent, Belgium. 5. Department of Radiology, Radboud University, Nijmegen Medical Centre, Nijmegen, The Netherlands. 6. Department of Radiation Oncology, Charité Universitätsmedizin Berlin, Berlin, Germany. 7. Institut Gustave Roussy, University of Paris Sud, Villejuif, France. 8. Department of Radiation Oncology and Experimental Cancer Research, Ghent University Hospital, Ghent, Belgium. 9. Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK. 10. Centre of Urological Surgery, Dialysis and Renal Transplantation, Fundeni Clinical Institute, Bucharest, Romania. 11. Department of Urology, University Medical Centre Utrecht, Utrecht, The Netherlands. 12. Department of Experimental and Clinical Medical Sciences, University of Udine, Udine, Italy. 13. Unit of Urology/Division of Oncology; URI; IRCCS Ospedale San Raffaele, Milan, Italy. Electronic address: briganti.alberto@hsr.it.
Abstract
BACKGROUND: The risk of unfavorable prostate cancer in active surveillance (AS) candidates is nonnegligible. However, what represents an adverse pathologic outcome in this setting is unknown. We aimed at assessing the optimal definition of misclassification and its effect on recurrence in AS candidates treated with radical prostatectomy (RP). MATERIALS AND METHODS: Overall, 1,710 patients eligible for AS according to Prostate Cancer Research International: Active Surveillance criteria treated with RP between 2000 and 2013 at 3 centers were evaluated. Patients were stratified according to pathology results at RP: organ-confined disease and pathologic Gleason score ≤ 6 (group 1); organ-confined disease and Gleason score 3+4 (group 2); and non-organ-confined disease, Gleason score ≥ 4+3, and nodal invasion (group 3). Biochemical recurrence (BCR) was defined as 2 consecutive prostate-specific antigen (PSA) ≥ 0.2 ng/ml. Kaplan-Meier curves assessed time to BCR. Multivariable Cox regression analyses tested the association between pathologic features and BCR. Multivariable logistic regression analyses identified the predictors of adverse pathologic characteristics. RESULTS: Overall, 926 (54.2%), 653 (33.0%), and 220 (12.9%) patients were categorized in groups 1, 2, and 3, respectively. Median follow-up was 32.2 months. The 5-year BCR-free survival rate was 94.2%. Patients in group 3 had lower BCR-free survival rates compared with those in group 1 (79.1% vs. 97.0%, P<0.001). No differences were observed between patients included in group 1 vs. group 2 (97.0% vs. 94.7%, P = 0.1). These results were confirmed at multivariable analyses and after stratification according to margin status. Older age and PSA density ≥ 10 ng/ml/ml were associated with higher risk of unfavorable pathologic characteristics (i.e., inclusion in group 3; all P<0.001). CONCLUSIONS: Among patients eligible for AS treated with RP, only men with Gleason score ≥ 4+3 or non-organ-confined disease at final pathology were at increased risk of BCR. These individuals represent the real misclassified AS patients, who can be predicted based on older age and higher PSA density.
BACKGROUND: The risk of unfavorable prostate cancer in active surveillance (AS) candidates is nonnegligible. However, what represents an adverse pathologic outcome in this setting is unknown. We aimed at assessing the optimal definition of misclassification and its effect on recurrence in AS candidates treated with radical prostatectomy (RP). MATERIALS AND METHODS: Overall, 1,710 patients eligible for AS according to Prostate Cancer Research International: Active Surveillance criteria treated with RP between 2000 and 2013 at 3 centers were evaluated. Patients were stratified according to pathology results at RP: organ-confined disease and pathologic Gleason score ≤ 6 (group 1); organ-confined disease and Gleason score 3+4 (group 2); and non-organ-confined disease, Gleason score ≥ 4+3, and nodal invasion (group 3). Biochemical recurrence (BCR) was defined as 2 consecutive prostate-specific antigen (PSA) ≥ 0.2 ng/ml. Kaplan-Meier curves assessed time to BCR. Multivariable Cox regression analyses tested the association between pathologic features and BCR. Multivariable logistic regression analyses identified the predictors of adverse pathologic characteristics. RESULTS: Overall, 926 (54.2%), 653 (33.0%), and 220 (12.9%) patients were categorized in groups 1, 2, and 3, respectively. Median follow-up was 32.2 months. The 5-year BCR-free survival rate was 94.2%. Patients in group 3 had lower BCR-free survival rates compared with those in group 1 (79.1% vs. 97.0%, P<0.001). No differences were observed between patients included in group 1 vs. group 2 (97.0% vs. 94.7%, P = 0.1). These results were confirmed at multivariable analyses and after stratification according to margin status. Older age and PSA density ≥ 10 ng/ml/ml were associated with higher risk of unfavorable pathologic characteristics (i.e., inclusion in group 3; all P<0.001). CONCLUSIONS: Among patients eligible for AS treated with RP, only men with Gleason score ≥ 4+3 or non-organ-confined disease at final pathology were at increased risk of BCR. These individuals represent the real misclassified AS patients, who can be predicted based on older age and higher PSA density.
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Authors: Pieter J L De Visschere; Alberto Briganti; Jurgen J Fütterer; Pirus Ghadjar; Hendrik Isbarn; Christophe Massard; Piet Ost; Prasanna Sooriakumaran; Cristian I Surcel; Massimo Valerio; Roderick C N van den Bergh; Guillaume Ploussard; Gianluca Giannarini; Geert M Villeirs Journal: Insights Imaging Date: 2016-02-04