Evidence map›Paper›PMID 27324190›Full record

Trial reportClinical pharmacokinetics2017

Modeling the Relationship Between Exposure to Abiraterone and Prostate-Specific Antigen Dynamics in Patients with Metastatic Castration-Resistant Prostate Cancer.

Xu Steven Xu, Charles J Ryan, Kim Stuyckens, Matthew R Smith, Fred Saad, Thomas W Griffin, Youn C Park, Margaret K Yu, Peter De Porre, An Vermeulen and 2 more

Abstract readClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in Clinical pharmacokinetics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.8field-weighted citation impact, top 9% 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

9 citing papers in PubMed, 18 citations in OpenAlex.

  1. Trial
  2. Article
  3. Observational
  4. Article
  5. Review
  6. Article
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 3 countries.

Xu Steven XuJanssen Research & Development, 920 Route 202, Raritan, NJ, 08869, USA. sxu26@its.jnj.com.
Charles J RyanHelen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.
Kim StuyckensJanssen Research & Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.
Matthew R SmithHarvard Medical School, Massachusetts General Hospital, Boston, MA, USA.
Fred SaadUniversity of Montréal, Montréal, QC, Canada.
Thomas W GriffinJanssen Research & Development, Los Angeles, CA, USA.
Youn C ParkJanssen Research & Development, 920 Route 202, Raritan, NJ, 08869, USA.
Margaret K YuJanssen Research & Development, Los Angeles, CA, USA.
Peter De PorreJanssen Research & Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.
An VermeulenJanssen Research & Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.
Italo PoggesiJanssen Research & Development, a Division of Janssen Pharmaceutica NV, Beerse, Belgium.
Partha NandyJanssen Research & Development, 920 Route 202, Raritan, NJ, 08869, USA.
Janssen (United States) · USJanssen (Belgium) · BEHarvard University · USUniversité de Montréal · CAUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesRecent analysis revealed strong associations between prostate-specific antigen (PSA) dynamics and overall survival (OS) in metastatic castration-resistant prostate cancer (mCRPC) and supported PSA dynamics as bridging surrogacy endpoints for clinical benefit from treatment with abiraterone acetate plus prednisone. This analysis aimed to investigate the abiraterone exposure-PSA dynamics relationship in mCRPC.

methodsAbiraterone pharmacokinetics-PSA models were constructed using data from the COU-AA-301 (chemotherapy-pretreated) and COU-AA-302 (chemotherapy-naïve) trials comparing abiraterone acetate 1000 mg/day plus prednisone 5 mg twice daily with prednisone alone in mCRPC. The drug effect-PSA dynamics relationship was modeled as a function of selected pharmacokinetic measures. The influences of baseline demographic variables, laboratory values, and disease status on PSA dynamics were assessed.

resultsA tumor growth inhibition model best described PSA dynamics post-treatment with abiraterone acetate. Abiraterone acetate treatment in chemotherapy-pretreated and chemotherapy-naïve patients increased the PSA decay rate (k

conclusionThe model appropriately described the exposure-response relationship between abiraterone and PSA dynamics in chemotherapy-pretreated and chemotherapy-naïve patients following oral administration of abiraterone acetate.

Indexed as

Models, BiologicalAbiraterone AcetateArea Under CurveDrug Therapy, CombinationHumansL-Lactate DehydrogenaseMalePrednisoneProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantSeverity of Illness IndexSocioeconomic FactorsTestosteroneAbiraterone AcetateL-Lactate DehydrogenasePrednisoneProstate-Specific AntigenTestosterone

Identifiers

PMID27324190
OpenAlexW2474545910

What OpenQuestion holds

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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.