Evidence map›Paper›PMID 37085425›Full record

Trial reportEuropean urology2024

Bone Biomarkers and Subsequent Survival in Men with Hormone-sensitive Prostate Cancer: Results from the SWOG S1216 Phase 3 Trial of Androgen Deprivation Therapy with or Without Orteronel.

Primo N Lara, Edward Mayerson, Erik Gertz, Catherine Tangen, Amir Goldkorn, Marta van Loan, Maha Hussain, Shilpa Gupta, Jingsong Zhang, Mamta Parikh and 6 more

Open access · greenAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in European urology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.6field-weighted citation impact, top 10% 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

9 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. 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

16 authors at 12 institutions in 1 country.

Primo N LaraUniversity of California Davis Comprehensive Cancer Center, Sacramento, CA, USA. Electronic address: pnlara@ucdavis.edu.
Edward MayersonSWOG Statistical Center, Seattle, WA, USA.
Erik GertzUS Department of Agriculture, Western Human Nutrition Research Center, University of California Davis, Davis, CA, USA.
Catherine TangenSWOG Statistical Center, Seattle, WA, USA.
Amir GoldkornUSC Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
Marta van LoanUS Department of Agriculture, Western Human Nutrition Research Center, University of California Davis, Davis, CA, USA.
Maha HussainNorthwestern University, Chicago, IL, USA.
Shilpa GuptaCleveland Clinic, Cleveland, OH, USA.
Jingsong ZhangMoffit Cancer Institute, Tampa Bay, FL, USA.
Mamta ParikhUniversity of California Davis Comprehensive Cancer Center, Sacramento, CA, USA.
Przemyslaw TwardowskiSt. John's Cancer Institute, Providence Health, Santa Monica, CA, USA.
David I QuinnUSC Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
Michael LeBlancSWOG Statistical Center, Seattle, WA, USA.
Nicholas J VogelzangComprehensive Cancer Centers of Nevada, Las Vegas, NV, USA.
Ian ThompsonChristus Santa Rosa Health System, San Antonio, TX Health, San Antonio, TX, USA.
Neeraj AgarwalHuntsman Cancer Institute, Salt Lake City, UT, USA.
Cancer Research And Biostatistics · USUSC Norris Comprehensive Cancer Center · USWestern Human Nutrition Research Center · USChristus Santa Rosa Health System · USCleveland Clinic · USComprehensive Cancer Centers of Nevada · USHuntsman Cancer Institute · USMoffitt Cancer Center · USNorthwestern University · USSaint John's Health Center · USUC Davis Comprehensive Cancer CenterUniversity of California, Davis · US

Funding

SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Michael L. LeBlanc · 2014 to 2026
$115.2M
Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Gina M Dayton · 2002 to 2026
$84.9M
UCDCCC NCTN UG1 PROGRAMUG1CA233340 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI GANDARA, DAVID R, VALICENTI, RICHARD · 2019 to 2025
$3.7M
NCI NIH HHS P30 CA093373NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233340
6 · The paper itself

Abstract

backgroundBone biomarkers are strongly prognostic for overall survival (OS) in men with castration-resistant prostate cancer but not fully established for hormone-sensitive prostate cancer (HSPC).

objectiveBone biomarkers in HSPC were prospectively evaluated as part of a phase 3 study of androgen deprivation therapy ± the CYP17 inhibitor orteronel. DESIGN, SETTING, AND

participantsPatients were randomly divided into training (n = 316) and validation (n = 633) sets. Recursive partitioning and Cox proportional hazard models were employed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Bone resorption (C-telopeptide and pyridinoline) and bone formation markers (C-terminal collagen propeptide and bone alkaline phosphatase) were assessed from patient sera. RESULTS AND LIMITATIONS: Of 1279 men, 949 had evaluable baseline bone biomarkers. Optimal cutoffs were identified to define elevated levels of each of the four biomarkers (all p < 0.05) that were associated with worse OS. After adjusting for clinical risk factors in the validation set, elevated bone biomarkers were statistically significantly associated with an increased risk of death (hazard ratios ranging from 1.37 to 1.92). Recursive partitioning algorithms applied to the training set identified three risk groups (low, intermediate, and poor) with differential OS outcomes (median OS: 8.2, 5.1, and 2.1 yr, respectively) based on combinations of bone biomarkers. These results were confirmed in the validation set.

conclusionsIn men with HSPC initiating androgen deprivation therapy, bone biomarkers are strongly and independently prognostic for OS. Bone biomarker levels alone or in combination with clinical covariates identify unique subsets of men with differential OS outcomes. These results validate the clinical value of bone biomarker assessment in the HSPC state, extending bone biomarker utility beyond the castration-resistant state. PATIENT SUMMARY: In men with newly diagnosed metastatic prostate cancer, high levels of bone turnover biomarkers are associated with a shorter lifespan.

Indexed as

ImidazolesNaphthalenesProstatic NeoplasmsProstatic Neoplasms, Castration-ResistantAndrogen AntagonistsAndrogensBiomarkersBiomarkers, TumorHumansMaleAndrogen AntagonistsAndrogensBiomarkersBiomarkers, TumorImidazolesNaphthalenesorteronelBiomarkersBone turnoverHormone sensitiveOverall survivalPredictivePrognosticProstate cancer

Identifiers

PMID37085425
PMCPMC10662935
OpenAlexW4366372494

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.