Patient and Context Factors in the Adoption of Active Surveillance for Low-Risk Prostate Cancer
Authors: Ciccone Giovannino , De Luca Stefano , Oderda Marco , Munoz Fernando , Krengli Marco , Allis Simona , Baima Carlo Giuliano , Barale Maurizio , Bartoncini Sara , Beldì Debora , Bellei Luca , Bellissimo Andrea Rocco , Bernardi Diego , Biamino Giorgio , Billia Michele , Borsa Roberto , Cante Domenico , Castelli Emanuele , Cattaneo Giovanni , Centrella Danilo , Collura Devis , Coppola Pietro , Dalmasso Ettore , Di Stasio Andrea , Fasolis Giuseppe , Fiorio Michele , Garibaldi Elisabetta , Girelli Giuseppe , Griffa Daniele , Guercio Stefano , Migliari Roberto , Molinaro Luca , Montefiore Franco , Montefusco Gabriele , Moroni Maurizio , Muto Giovanni , Ponti di Sant’Angelo Francesca , Ruggiero Luca , Ruo Redda Maria Grazia , Serao Armando , Squeo Maria Sara , Stancati Salvatore , Surleti Domenico , Varvello Francesco , Volpe Alessandro , Zaramella Stefano , Zarrelli Giovanni , Zitella Andrea , Bollito Enrico , Gontero Paolo , Porpiglia Francesco , Galassi Claudia , Bertetto Oscar ,   START Collaborative Group, Alessio Manuela , Annoscia Scipio , Antonini Daniela , Arrondini Marisa , Baldassarre Emanuele , Barbieri Paola , Bardari Franco , Belli Gaetano , Bellina Maurizio , Bellis Donata , Bonini Fabio , Bonvissuto Giulio , Bosco Martino , Bracco Francesco , Brizio Rodolfo , Brunetti Francesco , Buffardi Andrea , Cagnasso Silvia , Cagnazzi Eugenio , Calleris Giorgio , Campisi Paola , Caramanico Laura , Carchedi Mariateresa , Casalone Ugo , Cassoni Paola , Ceccarelli Manuela , Chiapello Germano , Cianini Elena , Clot Francesca , Cruciano Nicola , Cussotto Michele , De Angelis Paolo , De Giuli Paolo , Delmastro Elena , Delsedime Luisa , Di Martino Jessica , Dogliani Natalia , Ducret Chantal , Erra Stefania , Familiari Ubaldo , Faraone Nicola , Ferro Antonella , Feyles Elda , Fornari Alessandro , Forte Giuseppe , Fraire Flavio , Francese Alessia , Gabriele Pietro , Galla Andrea , Garrou Diletta , Gatti Marco , Giacobbe Alessandro , Giacomelli Giuseppe , Giordano Andrea , Grande Susanna , Guarneri Alessia , Guglielmetti Sandro , Guglielmini Pamela Francesca , Iandolo Maria , Iorio Giuseppe Carlo , Ivaldi Paola , Kurti Marisa , La Porta Maria Rosa , Leucci Giuliana , Liberale Fabiola , Lucci Chiarissi Marco , Manassero Monica , Manini Claudia , Manzo Marco , Marchioro Giansilvio , Mari Mauro , Maso Gloria , Massa Federica , Massarelli Massimo , Melloni Guglielmo , Mistrangelo Marinella , Monagheddu Chiara , Morabito Francesco , Moro Gregorio , Morra Ivano , Negro Carlo , Olivieri Valerio , Orlassino Renzo , Ortega Cinzia , Pacchioni Donatella , Pagani Alberto , Pagano Marco , Pagano Eva , Papotti Mauro , Pasquale Massimo , Patetta Roberta , Pezzuto Valter , Randone Donato , Ricardi Umberto , Ricci Daniele , Rosato Rosalba , Rossi Riccardo , Rossi Cristina , Rosso Diego , Saccona Fabio , Sedigh Omid , Talarico Ezio , Taraglio Stefano , Taurino Matteo , Treffiletti Salvatore , Tucci Marcello , Volante Marco , Zavattero Carla Angela , Zegna Luisa 
Published: October 2023

ImportanceAlthough active surveillance for patients with low-risk prostate cancer (LRPC) has been recommended for years, its adoption at the population level is often limited.ObjectiveTo make active surveillance available for patients with LRPC using a research framework and to compare patient characteristics and clinical outcomes between those who receive active surveillance vs radical treatments at diagnosis.Design, Setting, and ParticipantsThis population-based, prospective cohort study was designed by a large multidisciplinary group of specialists and patients’ representatives. The study was conducted within all 18 urology centers and 7 radiation oncology centers in the Piemonte and Valle d’Aosta Regional Oncology Network in Northwest Italy (approximate population, 4.5 million). Participants included patients with a new diagnosis of LRPC from June 2015 to December 2021. Data were analyzed from January to May 2023.ExposureAt diagnosis, all patients were informed of the available treatment options by the urologist and received an information leaflet describing the benefits and risks of active surveillance compared with active treatments, either radical prostatectomy (RP) or radiation treatment (RT). Patients choosing active surveillance were actively monitored with regular prostate-specific antigen testing, clinical examinations, and a rebiopsy at 12 months.Main Outcomes and MeasuresOutcomes of interest were proportion of patients choosing active surveillance or radical treatments, overall survival, and, for patients in active surveillance, treatment-free survival. Comparisons were analyzed with multivariable logistic or Cox models, considering centers as clusters.ResultsA total of 852 male patients (median [IQR] age, 70 [64-74] years) were included, and 706 patients (82.9%) chose active surveillance, with an increasing trend over time; 109 patients (12.8%) chose RP, and 37 patients (4.3%) chose RT. Median (IQR) follow-up was 57 (41-76) months. Worse prostate cancer prognostic factors were negatively associated with choosing active surveillance (eg, stage T2a vs T1c: odds ratio [OR], 0.51; 95% CI, 0.28-0.93), while patients who were older (eg, age ≥75 vs &amp;lt;65 years: OR, 4.27; 95% CI, 1.98-9.22), had higher comorbidity (Charlson Comorbidity Index ≥2 vs 0: OR, 1.98; 95% CI, 1.02-3.85), underwent an independent revision of the first prostate biopsy (OR, 2.35; 95% CI, 1.26-4.38) or underwent a multidisciplinary assessment (OR, 2.65; 95% CI, 1.38-5.11) were more likely to choose active surveillance vs active treatment. After adjustment, center at which a patient was treated continued to be an important factor in the choice of treatment (intraclass correlation coefficient, 18.6%). No differences were detected in overall survival between active treatment and active surveillance. Treatment-free survival in the active surveillance cohort was 59.0% (95% CI, 54.8%-62.9%) at 24 months, 54.5% (95% CI, 50.2%-58.6%) at 36 months, and 47.0% (95% CI, 42.2%-51.7%) at 48 months.Conclusions and RelevanceIn this population-based cohort study of patients with LRPC, a research framework at system level as well as favorable prognostic factors, a multidisciplinary approach, and an independent review of the first prostate biopsy at patient-level were positively associated with high uptake of active surveillance, a practice largely underused before this study.