Evidence map›Paper›PMID 25240761›Full record

Trial reportUrologic oncology2014

Assessment of the bone scan index in a randomized placebo-controlled trial of tasquinimod in men with metastatic castration-resistant prostate cancer (mCRPC).

Andrew J Armstrong, Reza Kaboteh, Michael A Carducci, Jan-Erik Damber, Walter M Stadler, Mats Hansen, Lars Edenbrandt, Göran Forsberg, Örjan Nordle, Roberto Pili and 1 more

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

Trial report in Urologic oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 3 pooled it
5.8field-weighted citation impact, top 4% 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

26 citing papers in PubMed, 3 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Article
  5. Flare phenomenon visualized byAnnals of nuclear medicine · 2024
    Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Quantification of bone flare onProstate cancer and prostatic diseases · 2019
    Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Article
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

11 authors at 8 institutions in 2 countries.

Andrew J ArmstrongDuke Cancer Institute and the Duke Prostate Center, Duke University, Durham, NC. Electronic address: andrew.armstrong@duke.edu.
Reza KabotehDepartment of Molecular and Clinical Medicine, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.
Michael A CarducciSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD.
Jan-Erik DamberDepartment of Urology, Institute of Clinical Sciences, Gothenburg University, Gothenburg, Sweden.
Walter M StadlerDepartment of Medicine, University of Chicago, Chicago, IL.
Mats HansenActive Biotech AB, Lund, Sweden.
Lars EdenbrandtDepartment of Molecular and Clinical Medicine, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden; Department of Clinical Sciences, Lund University, Malmö, Sweden; EXINI Diagnostics AB, Lund, Sweden.
Göran ForsbergActive Biotech AB, Lund, Sweden.
Örjan NordleActive Biotech AB, Lund, Sweden.
Roberto PiliRoswell Park Cancer Institute Genitourinary Program, Buffalo, NY.
Michael J MorrisGenitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Medicine, Weill Cornell Medical College, New York, NY.
Active Biotech (Sweden) · SEUniversity of Gothenburg · SECornell University · USDuke University · USJohns Hopkins University · USLund University · SERoswell Park Comprehensive Cancer Center · USUniversity of Chicago · US

Funding

Women's Cancer Research ProgramP30CA014236 · NCI · DUKE UNIVERSITY · PI JOHN N. NORTON · 1985 to 2026
$174.8M
NCI NIH HHS P30 CA014236
6 · The paper itself

Abstract

introductionDrug development and clinical decision making for patients with metastatic prostate cancer (PC) have been hindered by a lack of quantitative methods of assessing changes in bony disease burden that are associated with overall survival (OS). Bone scan index (BSI), a quantitative imaging biomarker of bone tumor burden, is prognostic in men with metastatic PC. We evaluated an automated method for BSI calculation for the association between BSI over time with clinical outcomes in a randomized double-blind trial of tasquinimod (TASQ) in men with metastatic castration-resistant PC (mCRPC).

methodsBone scans collected during central review from the TASQ trial were analyzed retrospectively using EXINIbone(BSI), an automated software package for BSI calculation. Associations between BSI and other prognostic biomarkers, progression-free survival, OS, and treatment were evaluated over time.

resultsOf 201 men (57 TASQ and 28 placebo), 85 contributed scans at baseline and week 12 of sufficient quality. Baseline BSI correlated with prostate-specific antigen and alkaline phosphatase levels and was associated with OS in univariate (hazard ratio [HR] = 1.42, P = 0.013) and multivariate (HR = 1.64, P<0.001) analyses. BSI worsening at 12 weeks was prognostic for progression-free survival (HR = 2.14 per BSI doubling, P<0.001) and OS (HR = 1.58, P = 0.033) in multivariate analyses including baseline BSI and TASQ treatment. TASQ delayed BSI progression.

conclusionsBSI and BSI changes over time were independently associated with OS in men with mCRPC. A delay in objective radiographic bone scan progression with TASQ is suggested; prospective evaluation of BSI progression and response criteria in phase 3 trials of men with mCRPC is warranted.

Indexed as

Bone and BonesBone NeoplasmsDiagnostic ImagingDisease-Free SurvivalDisease ProgressionDouble-Blind MethodHumansMalePrognosisProstatic Neoplasms, Castration-ResistantQuinolinesQuinolonesRadiographyRetrospective StudiesQuinolinesQuinolonestasquinimodAutomated detectionBone metastasesComputer-assisted diagnosisImage analysisProgression-free survivalProstate cancerRadionuclide imagingTasquinimod

Identifiers

PMID25240761
PMCPMC6341998
OpenAlexW2134049603

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.