PURPOSE: To test discontinuation rates during Active Surveillance (AS) in patients diagnosed with incidental prostate cancers (IPCa) vs. tumors diagnosed at prostate biopsies (BxPCa). METHODS: Retrospective single center analysis of 961 vs. 121 BxPCa vs. IPCa patients (2008-2020). Kaplan-Meier plots and multivariable Cox regression models tested four different outcomes: (1) any-cause discontinuation; (2) discontinuation due to ISUP GG upgrading; (3) biopsy discontinuation due to ISUP GG upgrading or > 3 positive cores; (4) biopsy discontinuation or suspicious extraprostatic extension at surveillance mpMRI. Then, multivariable logistic regression models tested rates of clinically significant PCa (csPCa) (ISUP GG ≥ 3 or pT ≥ 3a or pN1) after radical prostatectomy (RP). RESULTS: Median time follow-up was 35 (19-64) months. IPCa patients were at lower risk of any-cause (3-year survival: 79.3 vs. 66%; HR: 0.5, p = 0.001) and biopsy/MRI AS discontinuation (3-year survival: 82.3 vs. 72.7%; HR: 0.5, p = 0.001), compared to BxPCa patients. Conversely, IPCa patients exhibited same rates of biopsy discontinuation and ISUP GG upgrading over time, relative to BxPCa. In multivariable logistic regression models, IPCa patients were associated with higher rates of csPCa at RP (OR: 1.4, p = 0.03), relative to their BxPCa counterparts. CONCLUSION: AS represents a safe management strategy for IPCa. Compared to BxPCa, IPCa patients are less prone to experience any-cause and biopsy/MRI AS discontinuation. However, the two mentioned groups present similar rates of biopsy discontinuation and ISUP GG upgrading over time. In consequence, tailored AS protocols with scheduled repeated surveillance biopsies should be offered to all newly diagnosed IPCa patients.

Cancer Prognostics and Health Outcomes Unit Division of Urology University of Montréal Health Center Montréal QC Canada

Department of Oncology and Haemato Oncology Università degli Studi di Milano 20122 Milan Italy

Department of Pathology IEO European Institute of Oncology IRCCS Via Ripamonti 435 Milan Italy

Department of Radiotherapy IEO European Institute of Oncology IRCCS Via Ripamonti 435 Milan Italy

Department of Urology 2nd Faculty of Medicine Charles University Prague Czech Republic

Department of Urology Ehime University Graduate School of Medicine Ehime Japan

Department of Urology IEO European Institute of Oncology IRCCS Via Ripamonti 435 20141 Milan Italy

Department of Urology King Faisal Medical City Abha Saudi Arabia

Department of Urology Medical University of Vienna Vienna Austria

Department of Urology The Jikei University School of Medicine Tokyo Japan

Department of Urology University Medical Center Hamburg Eppendorf Hamburg Germany

Department of Urology University of Texas Southwestern Medical Center Dallas TX USA

Department of Urology Weill Cornell Medical College New York NY USA

European Association of Urology Research Foundation Arnhem The Netherlands

Institute for Urology and Reproductive Health Sechenov University Moscow Russia

Karl Landsteiner Institute of Urology and Andrology Vienna Austria

Precision Imaging and Research Unit Department of Medical Imaging and Radiation Sciences IEO European Institute of Oncology IRCCS 20141 Milan Italy

Research Division of Urology Department of Special Surgery The University of Jordan Amman Jordan

Università degli Studi di Milano Milan Italy

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