Evidence map›Paper›PMID 29590007›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2018

Prospective International Randomized Phase II Study of Low-Dose Abiraterone With Food Versus Standard Dose Abiraterone In Castration-Resistant Prostate Cancer.

Russell Z Szmulewitz, Cody J Peer, Abiola Ibraheem, Elia Martinez, Mark F Kozloff, Bradley Carthon, R Donald Harvey, Paul Fishkin, Wei Peng Yong, Edmund Chiong and 5 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
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, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 79 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 1 pooled it
17.4field-weighted citation impact, top 1% of its field
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

79 citing papers in PubMed, 1 synthesis or guideline pooled it, 177 citations in OpenAlex.

  1. Guideline
  2. Trial
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  6. Circulating and Intratumoral Adrenal Androgens Correlate with Response to Abiraterone in Men with Castration-Resistant Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
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  11. Article
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  13. Review
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19 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 1 institution in 1 country.

Russell Z SzmulewitzRussell Z. Szmulewitz, Abiola Ibraheem, Elia Martinez, Mark F. Kozloff, Chadi Nabhan, Theodore Karrison, Walter M. Stadler, and Mark J. Ratain, The University of Chicago, Chicago; Mark F. Kozloff, Ingalls Hospital, Harvey; Paul Fishkin, Illinois Cancer Care, Peoria, IL; Cody J. Peer and William D. Figg, National Cancer Institute, Rockville, MD; Bradley Carthon and R. Donald Harvey, Winship Cancer Institute of Emory University, Atlanta, GA; and Wei Peng Yong and Edmund Chiong, National University Cancer Institute, Singapore, Singapore.
Cody J PeerRussell Z. Szmulewitz, Abiola Ibraheem, Elia Martinez, Mark F. Kozloff, Chadi Nabhan, Theodore Karrison, Walter M. Stadler, and Mark J. Ratain, The University of Chicago, Chicago; Mark F. Kozloff, Ingalls Hospital, Harvey; Paul Fishkin, Illinois Cancer Care, Peoria, IL; Cody J. Peer and William D. Figg, National Cancer Institute, Rockville, MD; Bradley Carthon and R. Donald Harvey, Winship Cancer Institute of Emory University, Atlanta, GA; and Wei Peng Yong and Edmund Chiong, National University Cancer Institute, Singapore, Singapore.
Abiola IbraheemRussell Z. Szmulewitz, Abiola Ibraheem, Elia Martinez, Mark F. Kozloff, Chadi Nabhan, Theodore Karrison, Walter M. Stadler, and Mark J. Ratain, The University of Chicago, Chicago; Mark F. Kozloff, Ingalls Hospital, Harvey; Paul Fishkin, Illinois Cancer Care, Peoria, IL; Cody J. Peer and William D. Figg, National Cancer Institute, Rockville, MD; Bradley Carthon and R. Donald Harvey, Winship Cancer Institute of Emory University, Atlanta, GA; and Wei Peng Yong and Edmund Chiong, National University Cancer Institute, Singapore, Singapore.
Elia MartinezRussell Z. Szmulewitz, Abiola Ibraheem, Elia Martinez, Mark F. Kozloff, Chadi Nabhan, Theodore Karrison, Walter M. Stadler, and Mark J. Ratain, The University of Chicago, Chicago; Mark F. Kozloff, Ingalls Hospital, Harvey; Paul Fishkin, Illinois Cancer Care, Peoria, IL; Cody J. Peer and William D. Figg, National Cancer Institute, Rockville, MD; Bradley Carthon and R. Donald Harvey, Winship Cancer Institute of Emory University, Atlanta, GA; and Wei Peng Yong and Edmund Chiong, National University Cancer Institute, Singapore, Singapore.
Mark F KozloffRussell Z. Szmulewitz, Abiola Ibraheem, Elia Martinez, Mark F. Kozloff, Chadi Nabhan, Theodore Karrison, Walter M. Stadler, and Mark J. Ratain, The University of Chicago, Chicago; Mark F. Kozloff, Ingalls Hospital, Harvey; Paul Fishkin, Illinois Cancer Care, Peoria, IL; Cody J. Peer and William D. Figg, National Cancer Institute, Rockville, MD; Bradley Carthon and R. Donald Harvey, Winship Cancer Institute of Emory University, Atlanta, GA; and Wei Peng Yong and Edmund Chiong, National University Cancer Institute, Singapore, Singapore.
Bradley CarthonRussell Z. Szmulewitz, Abiola Ibraheem, Elia Martinez, Mark F. Kozloff, Chadi Nabhan, Theodore Karrison, Walter M. Stadler, and Mark J. Ratain, The University of Chicago, Chicago; Mark F. Kozloff, Ingalls Hospital, Harvey; Paul Fishkin, Illinois Cancer Care, Peoria, IL; Cody J. Peer and William D. Figg, National Cancer Institute, Rockville, MD; Bradley Carthon and R. Donald Harvey, Winship Cancer Institute of Emory University, Atlanta, GA; and Wei Peng Yong and Edmund Chiong, National University Cancer Institute, Singapore, Singapore.
R Donald HarveyRussell Z. Szmulewitz, Abiola Ibraheem, Elia Martinez, Mark F. Kozloff, Chadi Nabhan, Theodore Karrison, Walter M. Stadler, and Mark J. Ratain, The University of Chicago, Chicago; Mark F. Kozloff, Ingalls Hospital, Harvey; Paul Fishkin, Illinois Cancer Care, Peoria, IL; Cody J. Peer and William D. Figg, National Cancer Institute, Rockville, MD; Bradley Carthon and R. Donald Harvey, Winship Cancer Institute of Emory University, Atlanta, GA; and Wei Peng Yong and Edmund Chiong, National University Cancer Institute, Singapore, Singapore.
Paul FishkinRussell Z. Szmulewitz, Abiola Ibraheem, Elia Martinez, Mark F. Kozloff, Chadi Nabhan, Theodore Karrison, Walter M. Stadler, and Mark J. Ratain, The University of Chicago, Chicago; Mark F. Kozloff, Ingalls Hospital, Harvey; Paul Fishkin, Illinois Cancer Care, Peoria, IL; Cody J. Peer and William D. Figg, National Cancer Institute, Rockville, MD; Bradley Carthon and R. Donald Harvey, Winship Cancer Institute of Emory University, Atlanta, GA; and Wei Peng Yong and Edmund Chiong, National University Cancer Institute, Singapore, Singapore.
Wei Peng YongRussell Z. Szmulewitz, Abiola Ibraheem, Elia Martinez, Mark F. Kozloff, Chadi Nabhan, Theodore Karrison, Walter M. Stadler, and Mark J. Ratain, The University of Chicago, Chicago; Mark F. Kozloff, Ingalls Hospital, Harvey; Paul Fishkin, Illinois Cancer Care, Peoria, IL; Cody J. Peer and William D. Figg, National Cancer Institute, Rockville, MD; Bradley Carthon and R. Donald Harvey, Winship Cancer Institute of Emory University, Atlanta, GA; and Wei Peng Yong and Edmund Chiong, National University Cancer Institute, Singapore, Singapore.
Edmund ChiongRussell Z. Szmulewitz, Abiola Ibraheem, Elia Martinez, Mark F. Kozloff, Chadi Nabhan, Theodore Karrison, Walter M. Stadler, and Mark J. Ratain, The University of Chicago, Chicago; Mark F. Kozloff, Ingalls Hospital, Harvey; Paul Fishkin, Illinois Cancer Care, Peoria, IL; Cody J. Peer and William D. Figg, National Cancer Institute, Rockville, MD; Bradley Carthon and R. Donald Harvey, Winship Cancer Institute of Emory University, Atlanta, GA; and Wei Peng Yong and Edmund Chiong, National University Cancer Institute, Singapore, Singapore.
Chadi NabhanRussell Z. Szmulewitz, Abiola Ibraheem, Elia Martinez, Mark F. Kozloff, Chadi Nabhan, Theodore Karrison, Walter M. Stadler, and Mark J. Ratain, The University of Chicago, Chicago; Mark F. Kozloff, Ingalls Hospital, Harvey; Paul Fishkin, Illinois Cancer Care, Peoria, IL; Cody J. Peer and William D. Figg, National Cancer Institute, Rockville, MD; Bradley Carthon and R. Donald Harvey, Winship Cancer Institute of Emory University, Atlanta, GA; and Wei Peng Yong and Edmund Chiong, National University Cancer Institute, Singapore, Singapore.
Theodore KarrisonRussell Z. Szmulewitz, Abiola Ibraheem, Elia Martinez, Mark F. Kozloff, Chadi Nabhan, Theodore Karrison, Walter M. Stadler, and Mark J. Ratain, The University of Chicago, Chicago; Mark F. Kozloff, Ingalls Hospital, Harvey; Paul Fishkin, Illinois Cancer Care, Peoria, IL; Cody J. Peer and William D. Figg, National Cancer Institute, Rockville, MD; Bradley Carthon and R. Donald Harvey, Winship Cancer Institute of Emory University, Atlanta, GA; and Wei Peng Yong and Edmund Chiong, National University Cancer Institute, Singapore, Singapore.
William D FiggRussell Z. Szmulewitz, Abiola Ibraheem, Elia Martinez, Mark F. Kozloff, Chadi Nabhan, Theodore Karrison, Walter M. Stadler, and Mark J. Ratain, The University of Chicago, Chicago; Mark F. Kozloff, Ingalls Hospital, Harvey; Paul Fishkin, Illinois Cancer Care, Peoria, IL; Cody J. Peer and William D. Figg, National Cancer Institute, Rockville, MD; Bradley Carthon and R. Donald Harvey, Winship Cancer Institute of Emory University, Atlanta, GA; and Wei Peng Yong and Edmund Chiong, National University Cancer Institute, Singapore, Singapore.
Walter M StadlerRussell Z. Szmulewitz, Abiola Ibraheem, Elia Martinez, Mark F. Kozloff, Chadi Nabhan, Theodore Karrison, Walter M. Stadler, and Mark J. Ratain, The University of Chicago, Chicago; Mark F. Kozloff, Ingalls Hospital, Harvey; Paul Fishkin, Illinois Cancer Care, Peoria, IL; Cody J. Peer and William D. Figg, National Cancer Institute, Rockville, MD; Bradley Carthon and R. Donald Harvey, Winship Cancer Institute of Emory University, Atlanta, GA; and Wei Peng Yong and Edmund Chiong, National University Cancer Institute, Singapore, Singapore.
Mark J RatainRussell Z. Szmulewitz, Abiola Ibraheem, Elia Martinez, Mark F. Kozloff, Chadi Nabhan, Theodore Karrison, Walter M. Stadler, and Mark J. Ratain, The University of Chicago, Chicago; Mark F. Kozloff, Ingalls Hospital, Harvey; Paul Fishkin, Illinois Cancer Care, Peoria, IL; Cody J. Peer and William D. Figg, National Cancer Institute, Rockville, MD; Bradley Carthon and R. Donald Harvey, Winship Cancer Institute of Emory University, Atlanta, GA; and Wei Peng Yong and Edmund Chiong, National University Cancer Institute, Singapore, Singapore.
Markey Cancer Center · US

Funding

VIRAL ONCOLOGY CORE FACILITYP30CA014599 · NCI · UNIVERSITY OF CHICAGO · PI CHIEN-MIN KAO · 1985 to 2026
$122.1M
Targeting FOXA1-downstream pathways: a novel therapeutic strategy for castration-resistant prostate cancerP50CA180995 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI ABDULKADIR, SARKI A., HUSSAIN, MAHA H · 2015 to 2025
$19.9M
Using Clinical Pharmacology Principles to Develop New Anticancer TherapiesZICSC006537 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$14.4M
Drug Development for Prostate Cancer and other Metastatic ProcessesZIABC010547 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$10.2M
Pharmacokinetic and Pharmacodynamic Modeling of Anticancer AgentsZICBC010548 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2018
$5.9M
Intramural NIH HHS ZIC BC010548NCI NIH HHS P30 CA014599NCI NIH HHS P50 CA180995
6 · The paper itself

Abstract

Purpose Abiraterone acetate (AA) is a standard of care for metastatic castration-resistant prostate cancer (CRPC). Despite a large food effect, AA was administered under fasting conditions in its pivotal trials. We sought to test the hypothesis that low-dose AA (LOW; 250 mg with a low-fat meal) would have comparable activity to standard AA (STD; 1,000 mg fasting) in patients with CRPC. Patients and Methods Patients (n = 72) with progressive CRPC from seven institutions in the United States and Singapore were randomly assigned to STD or LOW. Both arms received prednisone 5 mg twice daily. Prostate-specific antigen (PSA) was assessed monthly, and testosterone/dehydroepiandrosterone sulfate were assessed every 12 weeks with disease burden radiographic assessments. Plasma was collected for drug concentrations. Log change in PSA, as a pharmacodynamic biomarker for efficacy, was the primary end point, using a noninferiority design. Progression-free survival (PFS), PSA response (≥ 50% reduction), change in androgen levels, and pharmacokinetics were secondary end points. Results Thirty-six patients were accrued to both arms. At 12 weeks, there was a greater effect on PSA in the LOW arm (mean log change, -1.59) compared with STD (-1.19), and noninferiority of LOW was established according to predefined criteria. The PSA response rate was 58% in LOW and 50% in STD, and the median PFS was approximately 9 months in both groups. Androgen levels decreased similarly in both arms. Although there was no difference in PSA response or PFS, abiraterone concentrations were higher in STD. Conclusion Low-dose AA (with low-fat breakfast) is noninferior to standard dosing with respect to PSA metrics. Given the pharmacoeconomic implications, these data warrant consideration by prescribers, payers, and patients. Additional studies are indicated to assess the long-term efficacy of this approach.

Indexed as

FoodAgedAged, 80 and overAndrostenesBiomarkers, TumorDehydroepiandrosteroneDose-Response Relationship, DrugFastingGlucocorticoidsHumansMaleMiddle AgedPrednisoneProspective StudiesProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantabirateroneAndrostenesBiomarkers, TumorDehydroepiandrosteroneGlucocorticoidsPrednisoneProstate-Specific AntigenTestosterone

Identifiers

PMID29590007
PMCPMC5941614
OpenAlexW2795001216

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.