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Original Investigation
August 27, 2020

Tailoring Intensity of Active Surveillance for Low-Risk Prostate Cancer Based on Individualized Prediction of Risk Stability

Author Affiliations
  • 1Helen Diller Family Comprehensive Cancer Center, Department of Urology, University of California, San Francisco
  • 2Department of Epidemiology & Biostatistics, University of California, San Francisco
  • 3Fred Hutchinson Cancer Research Center, Biostatistics Program, Public Health Sciences, Seattle, Washington
  • 4Fred Hutchinson Cancer Research Center, Cancer Prevention Program, Public Health Sciences, Seattle, Washington
  • 5Department of Urology, University of Washington, Seattle
  • 6Department of Urology, Stanford University, Stanford, California
  • 7Department of Urology, Veterans Affairs Puget Sound Health Care System, Seattle, Washington
  • 8Department of Urologic Sciences, University of British Columbia, Vancouver, Canada
  • 9Department of Urology, Eastern Virginia Medical School, Virginia Beach
  • 10Department of Urology, University of Michigan, Ann Arbor
  • 11Division of Human Biology, Fred Hutchinson Cancer Research Center, Seattle, Washington
  • 12CHRISTUS Medical Center Hospital, San Antonio, Texas
  • 13Division of Urology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
JAMA Oncol. Published online August 27, 2020. doi:10.1001/jamaoncol.2020.3187
Key Points

Question  Can a subset of men on active surveillance for prostate cancer be identified who have very low risks of intermediate-term reclassification to higher-risk disease?

Findings  In this multicenter cohort study including 850 men and an independent validation cohort of 533 men, 7 clinical parameters available for nearly all men on surveillance predicted nonreclassification at 4 years, with high negative predictive value.

Meaning  These findings suggest that active surveillance regimens can be tailored to individual risk, and many men can be followed up at longer intervals than those specified by most current protocols, thereby reducing anxiety, toxic effects, and cost.

Abstract

Importance  Active surveillance is increasingly recognized as the preferred standard of care for men with low-risk prostate cancer. However, active surveillance requires repeated assessments, including prostate-specific antigen tests and biopsies that may increase anxiety, risk of complications, and cost.

Objective  To identify and validate clinical parameters that can identify men who can safely defer follow-up prostate cancer assessments.

Design, Setting, and Participants  The Canary Prostate Active Surveillance Study (PASS) is a multicenter, prospective active surveillance cohort study initiated in July 2008, with ongoing accrual and a median follow-up period of 4.1 years.Men with prostate cancer managed with active surveillance from 9 North American academic medical centers were enrolled. Blood tests and biopsies were conducted on a defined schedule for least 5 years after enrollment. Model validation was performed among men at the University of California, San Francisco (UCSF) who did not enroll in PASS. Men with Gleason grade group 1 prostate cancer diagnosed since 2003 and enrolled in PASS before 2017 with at least 1 confirmatory biopsy after diagnosis were included. A total of 850 men met these criteria and had adequate follow-up. For the UCSF validation study, 533 active surveillance patients meeting the same criteria were identified. Exclusion criteria were treatment within 6 months of diagnosis, diagnosis before 2003, Gleason grade score of at least 2 at diagnosis or first surveillance biopsy, no surveillance biopsy, or missing data.

Exposures  Active surveillance for prostate cancer.

Main Outcomes and Measures  Time from confirmatory biopsy to reclassification, defined as Gleason grade group 2 or higher on subsequent biopsy.

Results  A total of 850 men (median [interquartile range] age, 64 [58-68] years; 774 [91%] White) were included in the PASS cohort. A total of 533 men (median [interquartile range] age, 61 [57-65] years; 422 [79%] White) were included in the UCSF cohort. Parameters predictive of reclassification on multivariable analysis included maximum percent positive cores (hazard ratio [HR], 1.30 [95% CI, 1.09-1.56]; P = .004), history of any negative biopsy after diagnosis (1 vs 0: HR, 0.52 [95% CI, 0.38-0.71]; P < .001 and ≥2 vs 0: HR, 0.18 [95% CI, 0.08-0.4]; P < .001), time since diagnosis (HR, 1.62 [95% CI, 1.28-2.05]; P < .001), body mass index (HR, 1.08 [95% CI, 1.05-1.12]; P < .001), prostate size (HR, 0.40 [95% CI, 0.25-0.62]; P < .001), prostate-specific antigen at diagnosis (HR, 1.51 [95% CI, 1.15-1.98]; P = .003), and prostate-specific antigen kinetics (HR, 1.46 [95% CI, 1.23-1.73]; P < .001). For prediction of nonreclassification at 4 years, the area under the receiver operating curve was 0.70 for the PASS cohort and 0.70 for the UCSF validation cohort. This model achieved a negative predictive value of 0.88 (95% CI, 0.83-0.94) for those in the bottom 25th percentile of risk and of 0.95 (95% CI, 0.89-1.00) for those in the bottom 10th percentile.

Conclusions and Relevance  In this study, among men with low-risk prostate cancer, heterogeneity prevailed in risk of subsequent disease reclassification. These findings suggest that active surveillance intensity can be modulated based on an individual’s risk parameters and that many men may be safely monitored with a substantially less intensive surveillance regimen.

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