Evidence map›Paper›PMID 37137444›Full record

Trial reportInternational journal of radiation oncology, biology, physics2023

Genomic Classifier Performance in Intermediate-Risk Prostate Cancer: Results From NRG Oncology/RTOG 0126 Randomized Phase 3 Trial.

Daniel E Spratt, Vinnie Y T Liu, Jeff Michalski, Elai Davicioni, Alejandro Berlin, Jeffry P Simko, Jason A Efstathiou, Phuoc T Tran, Howard M Sandler, William A Hall and 11 more

Erratum issuedAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Pooled it
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  18. Review
  19. Heterogeneity in precision oncology.Cambridge prisms. Precision medicine · 2024
    Review
  20. Prognostic utility of biopsy-basedFrontiers in oncology · 2024
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Daniel E SprattDepartment of Radiation Oncology, University Hospitals Seidman Cancer Center, Cleveland, Ohio. Electronic address: Daniel.Spratt@uhhospitals.org.
Vinnie Y T LiuVeracyte, Inc, South San Francisco, California.
Jeff MichalskiDepartment of Radiation Oncology, Washington University, St. Louis, Missouri.
Elai DavicioniVeracyte, Inc, South San Francisco, California.
Alejandro BerlinPrincess Margaret Cancer Centre, Cancer Clinical Research Unit, Toronto, Ontario, Canada.
Jeffry P SimkoDepartment of Pathology, UCSF Medical Center-Mount Zion, San Francisco, California.
Jason A EfstathiouDepartment of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Phuoc T TranDepartment of Pathology, University of Maryland, Baltimore, Maryland.
Howard M SandlerDepartment of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California.
William A HallDepartment of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin.
Darby J S ThompsonVeracyte, Inc, South San Francisco, California.
Matthew B ParliamentDivision of Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada.
Ian S DayesDivision of Radiation Oncology, Hamilton Regional Cancer Centre, Ontario, Canada.
Rohann Jonathan Mark CorreaDepartment of Oncology, London Regional Cancer Program, Ontario, Canada.
John M RobertsonDepartment of Radiation Oncology, Beaumont Health CCOP, Royal Oak, Michigan.
Elizabeth M GoreDepartment of Radiation Oncology, Milwaukee VA Medical Center, Milwaukee, Wisconsin.
Desiree E DoncalsDivision of Radiation Oncology, Akron City Hospital, Akron, Ohio.
Eric VigneaultDepartment of Radiation Oncology, CHU de Quebec Universite Laval, Quebec, Canada.
Luis SouhamiDepartment of Radiation Oncology, Cedars Cancer Centre, McGill University, Quebec, Canada.
Theodore G KarrisonNRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
Felix Y FengDepartment of Radiation Oncology, University of California San Francisco, San Francisco, California.

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Elaina Harper · 2014 to 2026
$146.4M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
NRG Oncology Biospecimen BankU24CA196067 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Tanner J. Freeman, Nilsa Del Carmen Ramirez Milan · 2015 to 2026
$42.6M
Case Comprehensive Cancer Center NCTN Lead Academic Participating SiteUG1CA233234 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI Aaron Thomas Gerds, Daniel Eidelberg Spratt · 2019 to 2026
$11.1M
Resource Sharing CoreU54CA273956 · NCI · UNIVERSITY OF MARYLAND BALTIMORE · PI Phuoc T. Tran · 2022 to 2026
$8.9M
Determining the clinical impact of gene expression testing in localized prostate cancerR01CA240991 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI MORGAN, TODD M., SPRATT, DANIEL EIDELBERG · 2019 to 2024
$3.1M
Quantifying and Personalizing the Clinical Benefit of Metastasis-Directed Therapy in Men with De Novo Oligometastatic Prostate CancerU01CA257638 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI Holly Hartman, Daniel Eidelberg Spratt · 2021 to 2026
$1.8M
Individualized estimates of treatment benefit from hormone therapy for men with prostate cancerR21CA274500 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SCHIPPER, MATTHEW, SPRATT, DANIEL EIDELBERG · 2023 to 2023
$387k
NCI NIH HHS R01 CA240991NCI NIH HHS R21 CA274500NCI NIH HHS U01 CA257638NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS U24 CA196067NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA233234
6 · The paper itself

Abstract

purposeIntermediate-risk prostate cancer is a heterogeneous disease state with diverse treatment options. The 22-gene Decipher genomic classifier (GC) retrospectively has shown to improve risk stratification in these patients. We assessed the performance of the GC in men with intermediate-risk disease enrolled in NRG Oncology/RTOG 01-26 with updated follow-up. METHODS AND MATERIALS: After National Cancer Institute approval, biopsy slides were collected from NRG Oncology/RTOG 01-26, a randomized phase 3 trial of men with intermediate-risk prostate cancer randomized to 70.2 Gy versus 79.2 Gy of radiation therapy without androgen deprivation therapy. RNA was extracted from the highest-grade tumor foci to generate the locked 22-gene GC model. The primary endpoint for this ancillary project was disease progression (composite of biochemical failure, local failure, distant metastasis, prostate cancer-specific mortality, and use of salvage therapy). Individual endpoints were also assessed. Fine-Gray or cause-specific Cox multivariable models were constructed adjusting for randomization arm and trial stratification factors.

resultsTwo-hundred fifteen patient samples passed quality control for analysis. The median follow-up was 12.8 years (range, 2.4-17.7). On multivariable analysis, the 22-gene GC (per 0.1 unit) was independently prognostic for disease progression (subdistribution hazard ratio [sHR], 1.12; 95% confidence interval [CI], 1.00-1.26; P = .04), biochemical failure (sHR, 1.22; 95% CI, 1.10-1.37; P < .001), distant metastasis (sHR, 1.28; 95% CI, 1.06-1.55; P = .01), and prostate cancer-specific mortality (sHR, 1.45; 95% CI, 1.20-1.76; P < .001). Ten-year distant metastasis in GC low-risk patients was 4% compared with 16% for GC high-risk patients. In patients with lower GC scores, the 10-year difference in metastasis-free survival rate between arms was -7%, compared with 21% for higher GC patients (P-interaction = .04).

conclusionsThis study represents the first validation of a biopsy-based gene expression classifier, assessing both its prognostic and predictive value, using data from a randomized phase 3 trial of intermediate-risk prostate cancer. Decipher improves risk stratification and can aid in treatment decision-making in men with intermediate-risk disease.

Indexed as

Prostatic NeoplasmsAndrogen AntagonistsDisease ProgressionGenomicsHumansMaleNeoplasm GradingProstate-Specific AntigenRetrospective StudiesAndrogen AntagonistsProstate-Specific Antigen

Identifiers

PMID37137444
PMCPMC10949135

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.