Evidence map›Paper›PMID 24637537›Full record

Trial reportProstate cancer and prostatic diseases2014

Androgen dynamics and serum PSA in patients treated with abiraterone acetate.

C J Ryan, W Peng, T Kheoh, E Welkowsky, C M Haqq, D W Chandler, H I Scher, A Molina

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Prostate cancer and prostatic diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
3.9field-weighted citation impact, top 7% 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

19 citing papers in PubMed, 38 citations in OpenAlex.

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  12. Contribution of Adrenal Glands to Intratumor Androgens and Growth of Castration-Resistant Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 2 countries.

C J RyanUniversity of California San Francisco, San Francisco, CA, USA.
W PengJanssen Research & Development, Los Angeles, CA, USA.
T KheohJanssen Research & Development, Los Angeles, CA, USA.
E WelkowskyJanssen Research & Development, Los Angeles, CA, USA.
C M HaqqJanssen Research & Development, Los Angeles, CA, USA.
D W ChandlerEndocrine Sciences, LabCorp, Calabasas, CA, USA.
H I ScherMemorial Sloan Kettering Cancer Center and Weill-Cornell Medical College, New York, NY, USA.
A MolinaJanssen Research & Development, Menlo Park, CA, USA.
Janssen (United States) · USJanssen (Belgium) · BELabCorp (United States) · USMemorial Sloan Kettering Cancer Center · USUniversity of California, San Francisco · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe analyzed the potential of abiraterone acetate (henceforth abiraterone) to reduce androgen levels below lower limits of quantification (LLOQ) and explored the association with changes in PSA decline in metastatic castration-resistant prostate cancer (mCRPC) patients.

methodsCOU-AA-301 is a 2:1 randomized, double-blind, placebo-controlled study comparing abiraterone (1000 mg q.d.) plus low-dose prednisone (5 mg b.i.d.) with placebo plus prednisone in mCRPC patients post docetaxel. Serum testosterone, androstenedione and dehydroepiandrosterone sulfate from baseline to week 12 were measured by novel ultrasensitive two-dimensional liquid chromatography coupled to tandem mass spectrometry assays in a subset of subjects in each arm (abiraterone plus prednisone, n=80; prednisone, n=38). The association between PSA response (< or =50% baseline) and undetectable androgens (week 12 androgen level below LLOQ) was analyzed using logistic regression.

resultsA significantly greater reduction in serum androgens was observed with abiraterone plus prednisone versus prednisone (all P < or = 0.0003), reaching undetectable levels for testosterone (47.2% versus 0%, respectively). A positive association was observed between achieving undetectable serum androgens and PSA decline (testosterone: odds ratio=1.54; 95% confidence interval: 0.546-4.347). Reduction of androgens to undetectable levels did not occur in all patients achieving a PSA response, and a PSA response did not occur in all patients achieving undetectable androgen levels.

conclusionsAbiraterone plus prednisone significantly reduced serum androgens, as measured by ultrasensitive assays and was generally associated with PSA response. However, androgen decline did not uniformly predict PSA decline suggesting ligand-independent or other mechanisms for mCRPC progression.

Indexed as

Abiraterone AcetateAndrogensAndrostenesDouble-Blind MethodHumansKallikreinsMalePrednisoneProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantTestosteroneTreatment OutcomeabirateroneAbiraterone AcetateAndrogensAndrostenesKallikreinsKLK3 protein, humanPrednisoneProstate-Specific AntigenTestosterone

Identifiers

PMID24637537
PMCPMC4020277
OpenAlexW1997042762

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.