Evidence map›Paper›PMID 30865549›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Prospective Multicenter Validation of Androgen Receptor Splice Variant 7 and Hormone Therapy Resistance in High-Risk Castration-Resistant Prostate Cancer: The PROPHECY Study.

Andrew J Armstrong, Susan Halabi, Jun Luo, David M Nanus, Paraskevi Giannakakou, Russell Z Szmulewitz, Daniel C Danila, Patrick Healy, Monika Anand, Colin J Rothwell and 17 more

Registry-linked trialAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02269982 (Development of Circulating Molecular Predictors of Chemotherapy and Novel Hormonal Therapy Benefit in Men With Metastatic Castration Resistant Prostate Cancer), which is not on this map. Cited by 217 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
217citing papers in PubMed, 8 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.

NCT02269982 completednot on this map

Development of Circulating Molecular Predictors of Chemotherapy and Novel Hormonal Therapy Benefit in Men With Metastatic Castration Resistant Prostate Cancer (mCRPC)

TypeobservationalSponsorDuke UniversityRan2015 to 2019Enrolled120ConditionsProstate CancerArmsAR-v7 assays
3 · Its place in the literature

Who cites it

217 citing papers in PubMed, 8 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Pooled it
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  9. Evolution of AR and Non-AR Alterations in ctDNA of Patients with Metastatic Prostate Cancer Treated in the Phase III Alliance A031201 Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
  10. Trial
  11. Trial
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  13. Phase Ib/II Study of Enzalutamide with Samotolisib (LY3023414) or Placebo in Patients with Metastatic Castration-Resistant Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Trial
  14. Phase II Multicenter Study of Enzalutamide in Metastatic Castration-Resistant Prostate Cancer to Identify Mechanisms Driving Resistance.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Trial
  15. Trial
  16. Trial
  17. Trial
  18. Review
  19. Article
  20. Review

157 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors.

Andrew J Armstrong1 Duke University, Durham, NC.
Susan Halabi1 Duke University, Durham, NC.
Jun Luo2 Johns Hopkins University, Baltimore, MD.
David M Nanus3 Weill Cornell Medical College, New York, NY.
Paraskevi Giannakakou3 Weill Cornell Medical College, New York, NY.
Russell Z Szmulewitz4 University of Chicago, Chicago, IL.
Daniel C Danila3 Weill Cornell Medical College, New York, NY.
Patrick Healy1 Duke University, Durham, NC.
Monika Anand1 Duke University, Durham, NC.
Colin J Rothwell1 Duke University, Durham, NC.
Julia Rasmussen1 Duke University, Durham, NC.
Blair Thornburg1 Duke University, Durham, NC.
William R Berry1 Duke University, Durham, NC.
Rhonda S Wilder1 Duke University, Durham, NC.
Changxue Lu2 Johns Hopkins University, Baltimore, MD.
Yan Chen2 Johns Hopkins University, Baltimore, MD.
John L Silberstein2 Johns Hopkins University, Baltimore, MD.
Gabor Kemeny1 Duke University, Durham, NC.
Giuseppe Galletti3 Weill Cornell Medical College, New York, NY.
Jason A Somarelli1 Duke University, Durham, NC.
Santosh Gupta1 Duke University, Durham, NC.
Simon G Gregory1 Duke University, Durham, NC.
Howard I Scher3 Weill Cornell Medical College, New York, NY.
Ryan Dittamore6 Epic Sciences, San Diego, CA.
Scott T Tagawa3 Weill Cornell Medical College, New York, NY.
Emmanuel S Antonarakis2 Johns Hopkins University, Baltimore, MD.
Daniel J George1 Duke University, Durham, NC.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Women's Cancer Research ProgramP30CA014236 · NCI · DUKE UNIVERSITY · PI JOHN N. NORTON · 1985 to 2026
$174.8M
Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
$86.2M
CANCER PHARMACOLOGYT32CA062948 · NCI · WEILL MEDICAL COLL OF CORNELL UNIV · PI LORRAINE J GUDAS · 1994 to 2026
$12.1M
Biomarkers of taxane chemotherapy response/resistance in prostate cancerR21CA216800 · NCI · WEILL MEDICAL COLL OF CORNELL UNIV · PI GIANNAKAKOU, PARASKEVI · 2018 to 2019
$400k
NCATS NIH HHS UL1 TR002384NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA014236NCI NIH HHS R21 CA216800NCI NIH HHS T32 CA062948
6 · The paper itself

Abstract

purposeAndrogen receptor splice variant 7 (AR-V7) results in a truncated receptor, which leads to ligand-independent constitutive activation that is not inhibited by anti-androgen therapies, including abiraterone or enzalutamide. Given that previous reports suggested that circulating tumor cell (CTC) AR-V7 detection is a poor prognostic indicator for the clinical efficacy of secondary hormone therapies, we conducted a prospective multicenter validation study. PATIENTS AND

methodsPROPHECY ( ClinicalTrials.gov identifier: NCT02269982) is a multicenter, prospective-blinded study of men with high-risk mCRPC starting abiraterone acetate or enzalutamide treatment. The primary objective was to validate the prognostic significance of baseline CTC AR-V7 on the basis of radiographic or clinical progression free-survival (PFS) by using the Johns Hopkins University modified-AdnaTest CTC AR-V7 mRNA assay and the Epic Sciences CTC nuclear-specific AR-V7 protein assay. Overall survival (OS) and prostate-specific antigen responses were secondary end points.

resultsWe enrolled 118 men with mCRPC who were starting abiraterone or enzalutamide treatment. AR-V7 detection by both the Johns Hopkins and Epic AR-V7 assays was independently associated with shorter PFS (hazard ratio, 1.9 [95% CI, 1.1 to 3.3;

conclusionDetection of AR-V7 in CTCs by two blood-based assays is independently associated with shorter PFS and OS with abiraterone or enzalutamide, and such men with mCRPC should be offered alternative treatments.

Indexed as

AgedAged, 80 and overAndrostenesBenzamidesHumansMaleMiddle AgedNeoplastic Cells, CirculatingNitrilesPhenylthiohydantoinPredictive Value of TestsProgression-Free SurvivalProspective StudiesProstatic Neoplasms, Castration-ResistantProtein IsoformsReceptors, AndrogenabirateroneAndrostenesAR protein, humanBenzamidesenzalutamideNitrilesPhenylthiohydantoinProtein IsoformsReceptors, Androgen

Identifiers

PMID30865549
PMCPMC6494355

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Registered trials

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.