A 17-gene Panel for Prediction of Adverse Prostate Cancer Pathologic Features

Prospective Clinical Validation and Utility

Scott Eggener, Lawrence I. Karsh, Tim Richardson, Alan W Shindel, Ruixiao Lu, Steven Rosenberg, Evan Goldfischer, Howard Korman, John Bennett, Jay Newmark, Bela S. Denes

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Objective: To validate the 17-gene Oncotype DX Genomic Prostate Score (GPS) biopsy-based gene expression assay as a predictor of adverse pathology (AP, Gleason score [pGS] ≥4+3 and/or ≥pT3) in a prospectively enrolled cohort. Methods: Between July 2014 and September 2015, 1200 men with very low-, low-, and favorable intermediate-risk prostate cancer enrolled in a multi-institutional prospective study of the GPS assay (NCT03502213). The subset who proceeded to immediate radical prostatectomy (RP) after GPS testing was included in a prespecified subanalysis of GPS on biopsy and its association with surgical AP on RP using logistic regression and receiver operating characteristic curves. The effect of GPS testing on physicians’ and patients’ attitudes about decision making was assessed with the Decisional Conflict Scale. Results: One hundred fourteen patients (treated by 59 physicians from 19 sites) elected RP and 40 (35%) had AP. GPS result was a significant predictor of AP (odds ratio per 20 GPS units [OR/20 units]: 2.2; 95% CI 1.2-4.1; P =.008) in univariable analysis and remained significant after adjustment for biopsy Gleason score, clinical T-stage, and logPSA (OR/20 units: 1.9; 95% CI 1.0-3.8; P =.04), or NCCN risk group (OR/20 units: 2.0; 95% CI 1.1-3.7; P =.02). Mean pre-GPS Decisional Conflict Scale score was 27 (95% CI 24-31), which improved significantly after GPS testing to 14 (95% CI 11-17) (P <.001). Conclusion: In this real-world multi-institutional study, the GPS assay was prospectively confirmed as an independent predictor of AP at surgery. GPS testing was associated with reduced patient decisional conflict.

Original languageEnglish (US)
JournalUrology
DOIs
StatePublished - Jan 1 2019
Externally publishedYes

Fingerprint

Prostate
Prostatic Neoplasms
Genes
Prostatectomy
Neoplasm Grading
Odds Ratio
Biopsy
Physicians
ROC Curve
Decision Making
Logistic Models
Prospective Studies
Pathology
Gene Expression

ASJC Scopus subject areas

  • Urology

Cite this

A 17-gene Panel for Prediction of Adverse Prostate Cancer Pathologic Features : Prospective Clinical Validation and Utility. / Eggener, Scott; Karsh, Lawrence I.; Richardson, Tim; Shindel, Alan W; Lu, Ruixiao; Rosenberg, Steven; Goldfischer, Evan; Korman, Howard; Bennett, John; Newmark, Jay; Denes, Bela S.

In: Urology, 01.01.2019.

Research output: Contribution to journalArticle

Eggener, S, Karsh, LI, Richardson, T, Shindel, AW, Lu, R, Rosenberg, S, Goldfischer, E, Korman, H, Bennett, J, Newmark, J & Denes, BS 2019, 'A 17-gene Panel for Prediction of Adverse Prostate Cancer Pathologic Features: Prospective Clinical Validation and Utility', Urology. https://doi.org/10.1016/j.urology.2018.11.050
Eggener, Scott ; Karsh, Lawrence I. ; Richardson, Tim ; Shindel, Alan W ; Lu, Ruixiao ; Rosenberg, Steven ; Goldfischer, Evan ; Korman, Howard ; Bennett, John ; Newmark, Jay ; Denes, Bela S. / A 17-gene Panel for Prediction of Adverse Prostate Cancer Pathologic Features : Prospective Clinical Validation and Utility. In: Urology. 2019.
@article{4274a44768864e4889b55c6e865cd7a2,
title = "A 17-gene Panel for Prediction of Adverse Prostate Cancer Pathologic Features: Prospective Clinical Validation and Utility",
abstract = "Objective: To validate the 17-gene Oncotype DX Genomic Prostate Score (GPS) biopsy-based gene expression assay as a predictor of adverse pathology (AP, Gleason score [pGS] ≥4+3 and/or ≥pT3) in a prospectively enrolled cohort. Methods: Between July 2014 and September 2015, 1200 men with very low-, low-, and favorable intermediate-risk prostate cancer enrolled in a multi-institutional prospective study of the GPS assay (NCT03502213). The subset who proceeded to immediate radical prostatectomy (RP) after GPS testing was included in a prespecified subanalysis of GPS on biopsy and its association with surgical AP on RP using logistic regression and receiver operating characteristic curves. The effect of GPS testing on physicians’ and patients’ attitudes about decision making was assessed with the Decisional Conflict Scale. Results: One hundred fourteen patients (treated by 59 physicians from 19 sites) elected RP and 40 (35{\%}) had AP. GPS result was a significant predictor of AP (odds ratio per 20 GPS units [OR/20 units]: 2.2; 95{\%} CI 1.2-4.1; P =.008) in univariable analysis and remained significant after adjustment for biopsy Gleason score, clinical T-stage, and logPSA (OR/20 units: 1.9; 95{\%} CI 1.0-3.8; P =.04), or NCCN risk group (OR/20 units: 2.0; 95{\%} CI 1.1-3.7; P =.02). Mean pre-GPS Decisional Conflict Scale score was 27 (95{\%} CI 24-31), which improved significantly after GPS testing to 14 (95{\%} CI 11-17) (P <.001). Conclusion: In this real-world multi-institutional study, the GPS assay was prospectively confirmed as an independent predictor of AP at surgery. GPS testing was associated with reduced patient decisional conflict.",
author = "Scott Eggener and Karsh, {Lawrence I.} and Tim Richardson and Shindel, {Alan W} and Ruixiao Lu and Steven Rosenberg and Evan Goldfischer and Howard Korman and John Bennett and Jay Newmark and Denes, {Bela S.}",
year = "2019",
month = "1",
day = "1",
doi = "10.1016/j.urology.2018.11.050",
language = "English (US)",
journal = "Urology",
issn = "1527-9995",
publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - A 17-gene Panel for Prediction of Adverse Prostate Cancer Pathologic Features

T2 - Prospective Clinical Validation and Utility

AU - Eggener, Scott

AU - Karsh, Lawrence I.

AU - Richardson, Tim

AU - Shindel, Alan W

AU - Lu, Ruixiao

AU - Rosenberg, Steven

AU - Goldfischer, Evan

AU - Korman, Howard

AU - Bennett, John

AU - Newmark, Jay

AU - Denes, Bela S.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Objective: To validate the 17-gene Oncotype DX Genomic Prostate Score (GPS) biopsy-based gene expression assay as a predictor of adverse pathology (AP, Gleason score [pGS] ≥4+3 and/or ≥pT3) in a prospectively enrolled cohort. Methods: Between July 2014 and September 2015, 1200 men with very low-, low-, and favorable intermediate-risk prostate cancer enrolled in a multi-institutional prospective study of the GPS assay (NCT03502213). The subset who proceeded to immediate radical prostatectomy (RP) after GPS testing was included in a prespecified subanalysis of GPS on biopsy and its association with surgical AP on RP using logistic regression and receiver operating characteristic curves. The effect of GPS testing on physicians’ and patients’ attitudes about decision making was assessed with the Decisional Conflict Scale. Results: One hundred fourteen patients (treated by 59 physicians from 19 sites) elected RP and 40 (35%) had AP. GPS result was a significant predictor of AP (odds ratio per 20 GPS units [OR/20 units]: 2.2; 95% CI 1.2-4.1; P =.008) in univariable analysis and remained significant after adjustment for biopsy Gleason score, clinical T-stage, and logPSA (OR/20 units: 1.9; 95% CI 1.0-3.8; P =.04), or NCCN risk group (OR/20 units: 2.0; 95% CI 1.1-3.7; P =.02). Mean pre-GPS Decisional Conflict Scale score was 27 (95% CI 24-31), which improved significantly after GPS testing to 14 (95% CI 11-17) (P <.001). Conclusion: In this real-world multi-institutional study, the GPS assay was prospectively confirmed as an independent predictor of AP at surgery. GPS testing was associated with reduced patient decisional conflict.

AB - Objective: To validate the 17-gene Oncotype DX Genomic Prostate Score (GPS) biopsy-based gene expression assay as a predictor of adverse pathology (AP, Gleason score [pGS] ≥4+3 and/or ≥pT3) in a prospectively enrolled cohort. Methods: Between July 2014 and September 2015, 1200 men with very low-, low-, and favorable intermediate-risk prostate cancer enrolled in a multi-institutional prospective study of the GPS assay (NCT03502213). The subset who proceeded to immediate radical prostatectomy (RP) after GPS testing was included in a prespecified subanalysis of GPS on biopsy and its association with surgical AP on RP using logistic regression and receiver operating characteristic curves. The effect of GPS testing on physicians’ and patients’ attitudes about decision making was assessed with the Decisional Conflict Scale. Results: One hundred fourteen patients (treated by 59 physicians from 19 sites) elected RP and 40 (35%) had AP. GPS result was a significant predictor of AP (odds ratio per 20 GPS units [OR/20 units]: 2.2; 95% CI 1.2-4.1; P =.008) in univariable analysis and remained significant after adjustment for biopsy Gleason score, clinical T-stage, and logPSA (OR/20 units: 1.9; 95% CI 1.0-3.8; P =.04), or NCCN risk group (OR/20 units: 2.0; 95% CI 1.1-3.7; P =.02). Mean pre-GPS Decisional Conflict Scale score was 27 (95% CI 24-31), which improved significantly after GPS testing to 14 (95% CI 11-17) (P <.001). Conclusion: In this real-world multi-institutional study, the GPS assay was prospectively confirmed as an independent predictor of AP at surgery. GPS testing was associated with reduced patient decisional conflict.

UR - http://www.scopus.com/inward/record.url?scp=85061053645&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85061053645&partnerID=8YFLogxK

U2 - 10.1016/j.urology.2018.11.050

DO - 10.1016/j.urology.2018.11.050

M3 - Article

JO - Urology

JF - Urology

SN - 1527-9995

ER -