Evidence map›Paper›PMID 18785254›Full record

Trial reportCancer2008

Phase 3, randomized, controlled trial of atrasentan in patients with nonmetastatic, hormone-refractory prostate cancer.

Joel B Nelson, William Love, Joseph L Chin, Fred Saad, Claude C Schulman, Darryl J Sleep, Jiang Qian, Joyce Steinberg, Michael Carducci, Atrasentan Phase 3 Study Group

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

Trial report in Cancer, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 93 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
93citing papers in PubMed, 2 pooled it
24.0field-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

93 citing papers in PubMed, 2 syntheses or guidelines pooled it, 245 citations in OpenAlex.

  1. Role of novel hormonal therapies in the management of non-metastatic castration-resistant prostate cancer: a literature-based meta-analysis of randomized trials.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
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  16. Endothelin and the tumor microenvironment: a finger in every pie.Clinical science (London, England : 1979) · 2024
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33 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 3 countries.

Joel B NelsonDepartment of Urology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania 15232, USA. nelsonjb@upmc.edu
William Love
Joseph L Chin
Fred Saad
Claude C Schulman
Darryl J Sleep
Jiang Qian
Joyce Steinberg
Michael Carducci
Atrasentan Phase 3 Study Group
Abbott Fund · USErasmus Hospital · BEHôpital Notre-Dame · CALondon Health Sciences Centre · CASidney Kimmel Comprehensive Cancer Center · USUniversity of Pittsburgh · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI Rosalie Wollett · 1985 to 2026
$208.6M
NCI NIH HHS P30 CA006973
6 · The paper itself

Abstract

backgroundAtrasentan is a potent, oral, selective endothelin-A (ET(A)) receptor antagonist that has clinical activity in patients with hormone-refractory prostate cancer (HRPC). In this article, the authors report the results from a phase 3, randomized, double-blind, placebo-controlled trial of atrasentan in patients with nonmetastatic HRPC.

methodsOf 941 patients who had adequate androgen suppression and no radiographic evidence of metastases but rising prostate-specific antigen (PSA) levels, 467 patients were randomized to receive atrasentan at a dose of 10 mg, and 474 patients were randomized to receive placebo daily. The primary endpoint was the time to disease progression (TTP), which was defined as the onset of metastases. Secondary endpoints were the time to PSA progression, change in bone alkaline phosphatase (BALP) levels, PSA doubling time, and overall survival.

resultsThere was a 93-day delay in the median TTP with atrasentan, but the difference from placebo in TTP was not statistically significant (P= .288). Large geographic differences in the median TTP were noted: in the US: The difference was 81 days longer with placebo; whereas, in non-US sites, the difference was 180 days longer with atrasentan. Atrasentan lengthened the PSA doubling time (P= .031) and slowed the increase in BALP (P< .001). The median survival was 1477 days with atrasentan and 1403 days with placebo. The most common adverse events associated with atrasentan were peripheral edema, nasal congestion, and headache, consistent with the vasodilatory properties of ET(A) receptor antagonists.

conclusionsAlthough the primary endpoint was not achieved, large regional differences in TTP were noted, suggesting that trial conduct may have influenced the results. The biologic activity was consistent with findings from other clinical trials of atrasentan in HRPC.

Indexed as

Administration, OralAgedAged, 80 and overAlkaline PhosphataseAtrasentanDisease ProgressionDouble-Blind MethodEndothelin-1HumansMaleMiddle AgedNeoplasms, Hormone-DependentPlacebosPrognosisProstatic NeoplasmsPyrrolidinesAlkaline PhosphataseAtrasentanEndothelin-1PlacebosPyrrolidines

Identifiers

PMID18785254
PMCPMC3085548
OpenAlexW2000853346

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.