Evidence map›Paper›PMID 19154507›Full record

Trial reportBJU international2009

Final analysis of a phase II trial using sorafenib for metastatic castration-resistant prostate cancer.

Jeanny B Aragon-Ching, Lokesh Jain, James L Gulley, Philip M Arlen, John J Wright, Seth M Steinberg, David Draper, Jürgen Venitz, Elizabeth Jones, Clara C Chen and 2 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in BJU international, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00090545 (A Phase II Study of BAY 43-9006), which is not on this map. Cited by 55 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 2 pooled it
13.4field-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.

NCT00090545 phase2completednot on this map

A Phase II Study of BAY 43-9006 (Sorafenib) in Metastatic, Androgen-Independent Prostate Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2004 to 2009Enrolled46ConditionsProstate CancerArmsBAY 43-9006
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 2 syntheses or guidelines pooled it, 115 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Unique Spectrum of Activating BRAF Alterations in Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  9. Review
  10. Article
  11. Review
  12. Observational
  13. Review
  14. Article
  15. Review
  16. Article
  17. Driven to metastasize: Kinases as potential therapeutic targets in prostate cancer.Proceedings of the National Academy of Sciences of the United States of America · 2016
    Article
  18. Review
  19. Article
  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

12 authors at 3 institutions in 1 country.

Jeanny B Aragon-ChingMedical Oncology Branch, National Cancer Institute, Bethesda, MD 20892, USA.
Lokesh Jain
James L Gulley
Philip M Arlen
John J Wright
Seth M Steinberg
David Draper
Jürgen Venitz
Elizabeth Jones
Clara C Chen
William D Figg
William L Dahut
Virginia Commonwealth University · USNational Cancer Institute · USCenter for Cancer Research · US

Funding

Sample Processing and Analytical Methods Development for New Anticancer AgentsZICSC006536 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$18.1M
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
Development of Anticancer AgentsZIASC006538 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$8.6M
The Evaluation of Novel Therapeutics for Genitourinary MalignanciesZIASC010098 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI DAHUT, WILLIAM L. · 2009 to 2022
$7.6M
EVALUATION OF NEW TREATMENTS FOR PROSTATE CANCERZ01SC006538 · SC · DIVISION OF CLINICAL SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 1997 to 2008
$647k
Intramural NIH HHS Z01 SC006538
6 · The paper itself

Abstract

objectiveTo determine if sorafenib is associated with an improved 4-month probability of progression-free survival, using radiographic and clinical criteria alone, in patients with metastatic castration-resistant prostate cancer. Secondary endpoints included pharmacokinetics, toxicity analysis and overall survival. PATIENTS AND

methodsThe study was an open-label, phase II, two-stage design, focusing on the results from the second stage, as criteria for progression were modified after completing the first stage. Sorafenib was given at a dose of 400 mg orally twice daily in 28-day cycles. Clinical and laboratory assessments were done every 4 weeks, and radiographic scans were obtained every 8 weeks.

resultsTwenty-four patients were accrued in the second stage; the median (range) age was 66 (49-85) years, the on-study prostate-specific antigen level was 68.45 (5.8-995) ng/mL, the Gleason score 8 (6-9) and Eastern Cooperative Oncology Group status 1 (in 17 patients). Of the 24 patients, 21 had previous chemotherapy with docetaxel. All patients had bony metastases, either alone (in 11) or with soft-tissue disease (in 13). One patient had a partial response; 10 patients had stable disease (median duration 18 weeks, range 15-48). At a median potential follow-up of 27.2 months, the median progression-free survival was 3.7 months and the median overall survival was 18.0 months. For the whole trial of 46 patients the median survival was 18.3 months. Most frequent toxicities included hand-foot skin reaction (grade 2 in nine patients, grade 3 in three), rash, abnormalities in liver function tests, and fatigue.

conclusionsSorafenib has moderate activity as a second-line treatment for metastatic castration-resistant prostate cancer.

Indexed as

AgedAged, 80 and overAntineoplastic AgentsBenzenesulfonatesBone NeoplasmsDisease-Free SurvivalGonadotropin-Releasing HormoneHumansMaleMiddle AgedNeoplasm MetastasisNiacinamideOrchiectomyPhenylurea CompoundsProstatic NeoplasmsPyridinesAntineoplastic AgentsBenzenesulfonatesGonadotropin-Releasing HormoneNiacinamidePhenylurea CompoundsPyridinesraf KinasesSorafenib

Identifiers

PMID19154507
PMCPMC2818665
OpenAlexW2078416515

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.