Evidence map›Paper›PMID 25336698›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2014

Sequential use of the androgen synthesis inhibitors ketoconazole and abiraterone acetate in castration-resistant prostate cancer and the predictive value of circulating androgens.

Won Kim, Li Zhang, John H Wilton, Gerald Fetterly, James L Mohler, Vivian Weinberg, Allison Morse, Russell Z Szmulewitz, Terence W Friedlander, Lawrence Fong and 5 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
3.4field-weighted citation impact, top 8% 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

22 citing papers in PubMed, 34 citations in OpenAlex.

  1. 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
    Trial
  2. Trial
  3. Trial
  4. Association of Tissue Abiraterone Levels andClinical cancer research : an official journal of the American Association for Cancer Research · 2017
    Trial
  5. Article
  6. Review
  7. Repurposing antifungal drugs for cancer therapy.Journal of advanced research · 2023
    Review
  8. Review
  9. The role of adrenal derived androgens in castration resistant prostate cancer.The Journal of steroid biochemistry and molecular biology · 2020
    Review
  10. 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
    Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Article
  16. Characterization of Prostate Cancer in a Functional Eunuch.Journal of the National Comprehensive Cancer Network : JNCCN · 2016
    Article
  17. Review
  18. Review
  19. Review
  20. Review
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

15 authors at 4 institutions in 1 country.

Won KimHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, California. won.kim@ucsf.edu.
Li ZhangHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, California.
John H WiltonDepartment of Medicine, PK/PD Core Resource, Roswell Park Cancer Institute, Buffalo, New York.
Gerald FetterlyDepartment of Medicine, PK/PD Core Resource, Roswell Park Cancer Institute, Buffalo, New York.
James L MohlerDepartment of Urology, Roswell Park Cancer Institute, Buffalo, New York.
Vivian WeinbergHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, California.
Allison MorseHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, California.
Russell Z SzmulewitzSection of Hematology and Oncology, University of Chicago, Chicago, Illinois.
Terence W FriedlanderHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, California.
Lawrence FongHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, California.
Amy M LinHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, California.
Andrea L HarzstarkHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, California.
Arturo MolinaJanssen Research and Development, Menlo Park, California.
Eric J SmallHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, California.
Charles J RyanHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, California.
UCSF Helen Diller Family Comprehensive Cancer Center · USRoswell Park Comprehensive Cancer Center · USMeta (United States) · USUniversity of Chicago · US

Funding

Two-Spirit Films in Indigenous Cancer HealthP30CA016056 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI Dean G. Tang · 1985 to 2026
$116.6M
Re-Engineering Translational Research at the University of ChicagoUL1TR000430 · NCATS · UNIVERSITY OF CHICAGO · PI SOLWAY, JULIAN · 2012 to 2016
$20.2M
Tumor stem cells in androgen independent prostate cancerP01CA077739 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI MOHLER, JAMES L · 1998 to 2014
$16.8M
NCATS NIH HHS UL1 TR000430NCI NIH HHS P01 CA077739NCI NIH HHS P01-CA77739NCI NIH HHS P30 CA016056NCI NIH HHS P30-CA16056
6 · The paper itself

Abstract

purposePatients previously treated with ketoconazole were excluded from phase III trials of abiraterone acetate due to potential overlapping mechanism of action. The purpose of this study was to determine the clinical utility of abiraterone and its impact on circulating androgens following ketoconazole. EXPERIMENTAL

designChemotherapy-naïve patients with progressive metastatic castration-resistant prostate cancer (mCRPC) and prior ketoconazole therapy ≥28 days received abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily. The primary endpoint was the proportion of patients with PSA response, defined as ≥30% PSA decline at 12 weeks. H0 = 0.30 versus H1 = 0.50 (α = 0.05, power = 0.83). Circulating androgen levels were measured using liquid chromatography tandem mass spectrometry.

resultsThirty-nine patients were included in the final analysis. Twenty (51%; 95% confidence interval, 36%-66%) patients had ≥30% PSA decline; the null hypothesis was rejected. Sixteen (41%) had ≥50% PSA decline. Median PFS (progression-free survival) was 16 weeks; median radiographic PFS (rPFS) was 36 weeks. Samples for measurement of baseline androgens were available in 37 patients. The PSA response proportion was 59% in 29 patients with DHEA ≥ limit of quantitation (LOQ), compared with 13% in 8 patients with DHEA < LOQ (P = 0.042). Median PFS was 6 and 16 weeks in DHEA < LOQ and DHEA ≥ LOQ patients, respectively (P = 0.017); median rPFS was 14 and 36 weeks in DHEA < LOQ and DHEA ≥ LOQ patients, respectively (P < 0.001).

conclusionsAbiraterone demonstrates modest clinical efficacy in mCRPC patients previously treated with ketoconazole. Patients with DHEA ≥ LOQ were more likely to demonstrate PSA responses and longer PFS. Analysis of circulating androgens merits further investigation as a biomarker for response to androgen synthesis inhibitor therapy.

Indexed as

Abiraterone AcetateAgedAged, 80 and overAndrogensAndrostenesHumansKetoconazoleMaleMiddle AgedNeoplasm MetastasisPrognosisProstatic Neoplasms, Castration-ResistantRetreatmentSteroid Synthesis InhibitorsTreatment OutcomeAbiraterone AcetateAndrogensAndrostenesKetoconazoleSteroid Synthesis Inhibitors

Identifiers

PMID25336698
PMCPMC4277885
OpenAlexW2115507326

What OpenQuestion holds

Textmetadata
LicenceTDM
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.