Evidence map›Paper›PMID 24043751›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

Denosumab and bone metastasis-free survival in men with nonmetastatic castration-resistant prostate cancer: exploratory analyses by baseline prostate-specific antigen doubling time.

Matthew R Smith, Fred Saad, Stephane Oudard, Neal Shore, Karim Fizazi, Paul Sieber, Bertrand Tombal, Ronaldo Damiao, Gavin Marx, Kurt Miller and 5 more

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 107 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
107citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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

107 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. 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
    Pooled it
  3. Pooled it
  4. Guideline
  5. Trial
  6. Trial
  7. Apalutamide and overall survival in non-metastatic castration-resistant prostate cancer.Annals of oncology : official journal of the European Society for Medical Oncology · 2019
    Trial
  8. Trial
  9. Trial
  10. Trial
  11. Safety of long-term denosumab therapy: results from the open label extension phase of two phase 3 studies in patients with metastatic breast and prostate cancer.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016
    Trial
  12. Article
  13. Observational
  14. Article
  15. Article
  16. Review
  17. Recent advances in drug treatment for prostate cancer.Japanese journal of radiology · 2025
    Review
  18. Article
  19. Review
  20. Article

47 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Matthew R SmithMatthew R. Smith, Massachusetts General Hospital Cancer Center, Boston, MA; Fred Saad, University of Montreal Hospital Center, Montreal, Quebec, Canada; Stephane Oudard, Georges Pompidou Hospital, Paris; Karim Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif, France; Neal Shore, Carolina Urological Research Center, Myrtle Beach, SC; Paul Sieber, Urological Associates of Lancaster, Lancaster, PA; Bertrand Tombal, Université Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, Belgium; Ronaldo Damiao, Hospital Universitario Pedro Ernesto, Rio de Janeiro, Brazil; Gavin Marx, Sydney Haematology and Oncology Clinic, University of Sydney, Wahroonga, New South Wales, Australia; Kurt Miller, Charité Berlin, Berlin, Germany; Peter Van Veldhuizen, Kansas City Veterans Affairs Medical Center, Kansas City, MO; Juan Morote, Hospital Vall d'Hebron, Barcelona, Spain; and Zhishen Ye, Roger Dansey, and Carsten Goessl, Amgen, Thousand Oaks, CA.
Fred Saad
Stephane Oudard
Neal Shore
Karim Fizazi
Paul Sieber
Bertrand Tombal
Ronaldo Damiao
Gavin Marx
Kurt Miller
Peter Van Veldhuizen
Juan Morote
Zhishen Ye
Roger Dansey
Carsten Goessl

Funding

Midcareer Investigator AwardK24CA121990 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI SMITH, MATTHEW RAYMOND · 2007 to 2016
$1.9M
NCI NIH HHS K24 CA121990
6 · The paper itself

Abstract

purposeDenosumab, an anti-RANK ligand monoclonal antibody, significantly increases bone metastasis-free survival (BMFS; hazard ratio [HR], 0.85; P = .028) and delays time to first bone metastasis in men with nonmetastatic castration-resistant prostate cancer (CRPC) and baseline prostate-specific antigen (PSA) ≥ 8.0 ng/mL and/or PSA doubling time (PSADT) ≤ 10.0 months. To identify men at greatest risk for bone metastasis or death, we evaluated relationships between PSA and PSADT with BMFS in the placebo group and the efficacy and safety of denosumab in men with PSADT ≤ 10, ≤ 6, and ≤ 4 months. PATIENTS AND

methodsA total of 1,432 men with nonmetastatic CRPC were randomly assigned 1:1 to monthly subcutaneous denosumab 120 mg or placebo. Enrollment began February 2006; primary analysis cutoff was July 2010, when approximately 660 men were anticipated to have developed bone metastases or died.

resultsIn the placebo group, shorter BMFS was observed as PSADT decreased below 8 months. In analyses by shorter baseline PSADT, denosumab consistently increased BMFS by a median of 6.0, 7.2, and 7.5 months among men with PSADT ≤ 10 (HR, 0.84; P = .042), ≤ 6 (HR, 0.77; P = .006), and ≤ 4 months (HR, 0.71; P = .004), respectively. Denosumab also consistently increased time to bone metastasis by PSADT subset. No difference in survival was observed between treatment groups for the overall study population or PSADT subsets.

conclusionPatients with shorter PSADT are at greater risk for bone metastasis or death. Denosumab consistently improves BMFS in men with shorter PSADT and seems to have the greatest treatment effects in men at high risk for progression.

Indexed as

AgedAged, 80 and overAndrogen AntagonistsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBiomarkers, TumorBone NeoplasmsCastrationDenosumabDisease-Free SurvivalDouble-Blind MethodDrug Administration ScheduleHumansInjections, SubcutaneousMaleOdds RatioAndrogen AntagonistsAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBiomarkers, TumorDenosumabProstate-Specific AntigenRANK Ligand

Identifiers

PMID24043751
PMCPMC3795889

What OpenQuestion holds

Textmetadata
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.