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

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

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

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.

Active surveillance for prostate cancer.

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.

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%).

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.

JAMA. 2024 May 30 [Epub ahead of print]

Lisa F Newcomb, Jeannette M Schenk, Yingye Zheng, Menghan Liu, Kehao Zhu, James D Brooks, Peter R Carroll, Atreya Dash, Claire M de la Calle, William J Ellis, Christopher P Filson, Martin E Gleave, Michael A Liss, Frances Martin, Jesse K McKenney, Todd M Morgan, Maria S Tretiakova, Andrew A Wagner, Peter S Nelson, Daniel W Lin

Cancer Prevention Program, Public Health Sciences, Fred Hutchinson Cancer Center, Seattle, Washington., Biostatistics Program, Public Health Sciences, Fred Hutchinson Cancer Center, Seattle, Washington., Department of Urology, Stanford University, Stanford, California., Department of Urology, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco., Department of Urology, Veterans Affairs Puget Sound Health Care System, Seattle, Washington., Department of Urology, University of Washington, Seattle., Department of Urology, Emory University School of Medicine, Atlanta, Georgia., Department of Urologic Sciences, University of British Columbia, Vancouver, British Columbia, Canada., Department of Urology, University of Texas Health Sciences Center, San Antonio., Department of Urology, Eastern Virginia Medical School, Virginia Beach., Robert J. Tomsich Pathology & Laboratory Medicine Institute, Cleveland Clinic, Cleveland, Ohio., Department of Urology, University of Michigan, Ann Arbor., Department of Pathology, University of Washington, Seattle., Division of Urology, Beth Israel Deaconess Medical Center, Boston, Massachusetts., Division of Human Biology, Fred Hutchinson Cancer Center, Seattle, Washington.