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Impact of Decipher Biopsy testing on clinical outcomes in localized prostate cancer in a prospective statewide collaborative

Abstract

Background

Decipher Biopsy is a commercially available gene expression classifier used in risk stratification of newly diagnosed prostate cancer (PCa). Currently, there are no prospective data evaluating its clinical utility. We seek to assess the clinical utility of Decipher Biopsy in localized PCa patients.

Methods

A multi-institutional study of 855 men who underwent Decipher Biopsy testing between February 2015 and October 2019. All patients were tracked through the prospective Michigan Urological Surgery Improvement Collaborative and linked to the Decipher Genomics Resource Information Database (GRID®; NCT02609269). Patient matching was performed by an independent third-party (ArborMetrix Inc.) using two or more unique identifiers. Cumulative incidence curves for time to treatment (TTT) and time to failure (TTF) were constructed using Kaplan–Meier estimates. Multivariable Cox proportional hazard models were used to evaluate the independent association of high-risk Decipher scores with the conversion from AS to radical therapy and treatment failure (biochemical failure or receipt of salvage therapy).

Results and limitations

Eight hundred fifty-five patients underwent Decipher Biopsy testing during the study period. Of the 855 men, 264 proceeded to AS (31%), and 454 (53%) received radical therapy. In men electing AS, after adjusting for NCCN risk group, age, PSA, prostate volume, body mass index, and percent positive cores, a high-risk Decipher score was independently associated with shorter TTT (HR 2.51, 95% CI 1.52–4.13 p < 0.001). Similarly, in patients that underwent radical therapy, a high-risk Decipher score was independently associated with TTF (HR 2.98, 95% CI 1.22–7.29, p = 0.01) on multivariable analysis. Follow-up time was a limitation.

Conclusion

In a prospective statewide registry, high-risk Decipher Biopsy score was strongly and independently associated with conversion from AS to definitive treatment and treatment failure. These real-world data support the clinical utility of Decipher Biopsy. An ongoing phase 3 randomized trial (NCT04396808) will provide level 1 evidence of the clinical impact of Decipher biopsy testing.

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Fig. 1: Correlation of decipher biopsy with clinical variables.
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Acknowledgements

Support for this project is provided by Blue Cross Blue Shield of Michigan; the Department of Defense Physician Research Training Award No. W81XWH-14-1-0287 (TMM); Alfred A. Taubman Institute; Prostate Cancer Foundation (TMM and DES); and National Cancer Institute Grant No. R01CA240991-01 (TMM and DES). The authors acknowledge the significant contribution of the clinical champions, urologists, and data abstractors in each participating Michigan Urological Surgery Improvement Collabora tive (MUSIC) practice.

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Contributions

RV: Project design, data acquistion, data interpretation, drafting manuscript, revising manuscript; RJ: project design, data acquistion, data interpretation; JQ: data acquistion, data interpretation; JT: drafting manuscript, revising manuscript; RT: drafting manuscript, revising manuscript; FF: drafting manuscript, revising manuscript; SL: data acquistion; AJ: data acquistion; SS: data acquistion; PH: data acquistion; AG: data acquistion; KG: data acquistion; FS: drafting manuscript, revising manuscript; MS: drafting manuscript, revising manuscript; RTD: drafting manuscript, revising manuscript; WJ: drafting manuscript, revising manuscript; MS: project design, data acquistion, data interpretation; DS: project design, data acquistion, data interpretation, drafting manuscript, revising manuscript; TM: project design, data acquistion, data interpretation, drafting manuscript, revising manuscript.

Corresponding author

Correspondence to Randy A. Vince Jr..

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Competing interests

DES: Personal Fees from Janssen, AstraZeneca, and Blue Earth. Funding from Janssen. TMM: Research funding: Decipher Biosciences and Myriad Genetics. Advisory Board: Blue Earth. JJT: Co-founder with equity interest, consulting fees: LynxDx, Inc.

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Vince, R.A., Jiang, R., Qi, J. et al. Impact of Decipher Biopsy testing on clinical outcomes in localized prostate cancer in a prospective statewide collaborative. Prostate Cancer Prostatic Dis 25, 677–683 (2022). https://doi.org/10.1038/s41391-021-00428-y

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