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Observational Study
. 2024 Jun 25;331(24):2084-2093.
doi: 10.1001/jama.2024.6695.

Long-Term Outcomes in Patients Using Protocol-Directed Active Surveillance for Prostate Cancer

Lisa F Newcomb  1   2 , Jeannette M Schenk  1 , Yingye Zheng  3 , Menghan Liu  3 , Kehao Zhu  3 , James D Brooks  4 , Peter R Carroll  5 , Atreya Dash  6 , Claire M de la Calle  2 , William J Ellis  2 , Christopher P Filson  7   8 , Martin E Gleave  9 , Michael A Liss  10 , Frances Martin  11 , Jesse K McKenney  12 , Todd M Morgan  13 , Maria S Tretiakova  14 , Andrew A Wagner  15 , Peter S Nelson  16 , Daniel W Lin  1   2
Affiliations
Observational Study

Long-Term Outcomes in Patients Using Protocol-Directed Active Surveillance for Prostate Cancer

Lisa F Newcomb et al. JAMA. .

Abstract

Importance: Outcomes from protocol-directed active surveillance for favorable-risk prostate cancers are needed to support decision-making.

Objective: To characterize the long-term oncological outcomes of patients receiving active surveillance in a multicenter, protocol-directed cohort.

Design, setting, and participants: The Canary Prostate Active Surveillance Study (PASS) is a prospective cohort study initiated in 2008. A cohort of 2155 men with favorable-risk prostate cancer and no prior treatment were enrolled at 10 North American centers through August 2022.

Exposure: Active surveillance for prostate cancer.

Main outcomes and measures: Cumulative incidence of biopsy grade reclassification, treatment, metastasis, prostate cancer mortality, overall mortality, and recurrence after treatment in patients treated after the first or subsequent surveillance biopsies.

Results: Among 2155 patients with localized prostate cancer, the median follow-up was 7.2 years, median age was 63 years, 83% were White, 7% were Black, 90% were diagnosed with grade group 1 cancer, and median prostate-specific antigen (PSA) was 5.2 ng/mL. Ten years after diagnosis, the incidence of biopsy grade reclassification and treatment were 43% (95% CI, 40%-45%) and 49% (95% CI, 47%-52%), respectively. There were 425 and 396 patients treated after confirmatory or subsequent surveillance biopsies (median of 1.5 and 4.6 years after diagnosis, respectively) and the 5-year rates of recurrence were 11% (95% CI, 7%-15%) and 8% (95% CI, 5%-11%), respectively. Progression to metastatic cancer occurred in 21 participants and there were 3 prostate cancer-related deaths. The estimated rates of metastasis or prostate cancer-specific mortality at 10 years after diagnosis were 1.4% (95% CI, 0.7%-2%) and 0.1% (95% CI, 0%-0.4%), respectively; overall mortality in the same time period was 5.1% (95% CI, 3.8%-6.4%).

Conclusions and relevance: In this study, 10 years after diagnosis, 49% of men remained free of progression or treatment, less than 2% developed metastatic disease, and less than 1% died of their disease. Later progression and treatment during surveillance were not associated with worse outcomes. These results demonstrate active surveillance as an effective management strategy for patients diagnosed with favorable-risk prostate cancer.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Newcomb reported receiving grants from NIH, Canary Foundation, and Institute for Prostate Cancer Research during the conduct of the study. Dr Zheng reported receiving grants from Fred Hutchinson Cancer Center and NIH during the conduct of the study. Mr Zhu reported receiving grants from NIH during the conduct of the study. Dr Liss reported receiving grants from NCI and Canary Foundation during the conduct of the study. Dr Tretiakova reported receiving grants from NIH during the conduct of the study. Dr Wagner reported receiving grants from Canary Foundation during the conduct of the study; being an investor and consultant for PatientApps Inc outside the submitted work; and participating in medical expert witness review for multiple firms. Dr Nelson reported receiving grants from NIH/NCI, Canary Foundation, and Janssen during the conduct of the study; and personal fees from Janssen, Pfizer, and Merck outside the submitted work. No other disclosures were reported.

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