Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2025 Jun;28(2):427-434.
doi: 10.1038/s41391-024-00888-y. Epub 2024 Sep 5.

Active surveillance selection and 3-year durability in intermediate-risk prostate cancer following genomic testing

Lauren Lenz  1 , Wyatt Clegg  1 , Diana Iliev  1 , Chelsea R Kasten  1 , Howard Korman  2   3 , Todd M Morgan  4 , Jason Hafron  5 , Alexander DeHaan  6 , Carl Olsson  7 , Ronald F Tutrone Jr  8 , Timothy Richardson  9 , Kevin Cline  10 , Paul M Yonover  11 , Jeff Jasper  1 , Todd Cohen  1 , Robert Finch  1 , Thomas P Slavin Jr  1 , Alexander Gutin  12
Affiliations
Observational Study

Active surveillance selection and 3-year durability in intermediate-risk prostate cancer following genomic testing

Lauren Lenz et al. Prostate Cancer Prostatic Dis. 2025 Jun.

Abstract

Background: Genomic testing can add risk stratification information to clinicopathological features in prostate cancer, aiding in shared medical decision-making between the clinician and patient regarding whether active surveillance (AS) or definitive treatment (DT) is most appropriate. Here we examined initial AS selection and 3-year AS durability in patients diagnosed with localized intermediate-risk prostate cancer who underwent Prolaris testing before treatment decision-making.

Methods: This retrospective observational cohort study included 3208 patients from 10 study sites who underwent Prolaris testing at diagnosis from September 2015 to December 2018. Prolaris utilizes a combined clinical cell cycle risk score calculated at diagnostic biopsy to stratify patients by the Prolaris AS threshold (below threshold, patient recommended to AS or above threshold, patient recommended to DT). AS selection rates and 3-year AS durability were compared in patients recommended to AS or DT by Prolaris testing. Univariable and multivariable logistic regression models and Cox proportional hazard models were used with molecular and clinical variables as predictors of initial treatment decision and AS durability, respectively.

Results: AS selection was ~2 times higher in patients recommended to AS by Prolaris testing than in those recommended to DT (p < 0.0001). Three-year AS durability was ~1.5 times higher in patients recommended to AS by Prolaris testing than in those recommended to DT (p < 0.0001). Prolaris treatment recommendation remained a statistically significant predictor of initial AS selection and AS durability after accounting for CAPRA or Gleason scores.

Conclusions: Prolaris added significant information to clinical risk stratification to aid in treatment decision making. Intermediate-risk prostate cancer patients who were recommended to AS by Prolaris were more likely to initially pursue AS and were more likely to remain on AS at 3 years post-diagnosis than patients recommended to DT.

PubMed Disclaimer

Conflict of interest statement

Competing interests: The authors report the following competing interests: LL, WC, DI, CRK, JJ, TC, RF, TPS, and AG were employees of Myriad Genetics, Inc at the time of the study and received salary and stock options. TPS additionally reports a consulting or advisory role and stock or other ownership interests for Oncodea. AG additionally reports a consulting or advisory role for DermTech. HK reports research funding from Myriad Genetics, Inc. TMM reports consulting or advisory roles for Myriad Genetics, Inc., TERUMO, Blue Earth Diagnostics, Stratify Genomics, Myovant Sciences, Tempus, and Foundation Medicine, as well as institutional research funding from Myriad Genetics, Inc., MDxHealth, and GenomeDx. JH reports consulting or advisory roles for Astellas Pharma, Dendreon, Lilly, Janssen Biotech, LynxDx, Myriad Genetics, Inc., Myovant Sciences, Pfizer, and Promaxo; honoraria, speaker’s bureau, or other compensation from Astellas Pharma, Amgen, Bayer, Blue Earth Diagnostics, Dendreon, Janssen Biotech, Lantheus Medical Imaging, Merck, Myriad Genetics, Inc., Myovant Sciences, Pfizer, Procept BioRobotics, Tolmar, and UroGen Pharma; and institutional research funding from Astellas Pharma, Bayer, Dendreon, Janssen Biotech, Lipella Pharmaceuticals, Merck, miR Scientific, Myriad Genetics, Inc., Myovant Sciences, and Pfizer. RFT reports consulting or advisory roles for Exosome Diagnostics, Myovant Sciences, Nymox, and Novartis; speaker’s bureau fees from Medivation/Astellas, Exosome Diagnostics, and Pfizer; stock or other ownership interests in Compass Therapeutics, GlaxoSmithKline, Nymox, Novartis, Myovant Sciences, and Veru; and institutional research funding from Medivation/Astellas, Janssen Oncology, Bayer, MDxHealth, Genomic Health, Exosome Diagnostics, Advantagene, Merck, POINT Biopharma, Dendreon, and Veru. All other authors have no competing interests to report. Ethics approval and consent to participate: The analysis described in this manuscript was performed using de-identified data obtained during the course of routine healthcare operations. Individuals provided written informed consent for clinical testing. A Waiver of Informed Consent and Full Waiver of HIPAA Authorization were obtained from Advarra IRB (Reference Number: Pro00047891). The study was performed in accordance with oversight from Advarra IRB; all participating sites were overseen for continued activities.

Figures

Fig. 1
Fig. 1. Distribution of Prolaris treatment recommendation and initial treatment decisions.
The numbers and proportions of patients in the AS Selection Cohort (N = 3208) with a Prolaris treatment recommendation to AS (n = 1470) or DT (n = 1738) and who were initially managed with AS (dark blue) or DT (light blue) are shown in the mosaic plot. Colored areas and listed percentages represent the percent of the AS Selection Cohort. AS active surveillance, DT definitive treatment.
Fig. 2
Fig. 2. AS durability by Prolaris treatment recommendation over 3 years among patients in the AS Durability Subcohort.
Kaplan–Meier estimates of AS durability over 3 years after diagnosis were calculated for patients who initially selected AS (N = 960) who were recommended to AS (dashed green; n = 605) or recommended to DT (solid orange; n = 355) by Prolaris testing. Shaded areas represent 95% CI. The number of patients at risk at each time point is shown below the graph. AS active surveillance, DT definitive treatment.
See this image and copyright information in PMC

References

    1. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Prostate Cancer. Version 1.2023. Published: 16 September 2022. In.
    1. Wei JT, Barocas D, Carlsson S, Coakley F, Eggener S, Etzioni R, et al. Early detection of prostate cancer: AUA/SUO guideline part II: considerations for a prostate biopsy. J Urol. 2023;210:54–63. - PMC - PubMed
    1. Eastham JA, Auffenberg GB, Barocas DA, Chou R, Crispino T, Davis JW, et al. Clinically localized prostate cancer: AUA/ASTRO guideline, part I: introduction, risk assessment, staging, and risk-based management. J Urol. 2022;208:10–18. - PubMed
    1. Walker CH, Marchetti KA, Singhal U, Morgan TM. Active surveillance for prostate cancer: selection criteria, guidelines, and outcomes. World J Urol. 2022;40:35–42. - PubMed
    1. Cooperberg M, Meeks W, Fang R, Gaylis F, Catalona W, Makarov D. MP43-03 Active surveillance for low-risk prostate cancer: time trends and variation in the AUA Quality (AQUA) registry. J Urol. 2022;207(Supplement 5):e740.

Publication types

Substances