Evidence map›Paper›PMID 33662287›Full record

SynthesisThe Lancet. Oncology2021

Intermediate clinical endpoints for surrogacy in localised prostate cancer: an aggregate meta-analysis.

Laila A Gharzai, Ralph Jiang, David Wallington, Gavin Jones, Samuel Birer, Neil Jairath, Elizabeth M Jaworski, Matthew R McFarlane, Brandon A Mahal, Paul L Nguyen and 15 more

2 registry-linked trialsOpen access · greenAbstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in The Lancet. Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 51 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
51citing papers in PubMed, 3 pooled it
14.2field-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.

NCT06027892 narecruitingnot on this mapstarted 2022, after this paper: background citation

Two-fraction Versus Five-fraction Stereotactic Radiotherapy for Localized Low- and Favorable Intermediate-risk Prostate Cancer: SABR-Dual

TypeinterventionalSponsorRabin Medical CenterRan2022 to 2032Enrolled562ConditionsPROSTATE CANCERArmsTwo-fraction stereotactic radiotherapy, Five-fraction stereotactic radiotherapy
NCT06223295 narecruitingnot on this mapstarted 2024, after this paper: background citation

Effectiveness of Focal Therapy in Men With Prostate Cancer

TypeinterventionalSponsorRadboud University Medical CenterRan2024 to 2031Enrolled356ConditionsProstate Cancer, Prostate NeoplasmArmsFocal therapy, Usual care
3 · Its place in the literature

Who cites it

51 citing papers in PubMed, 3 syntheses or guidelines pooled it, 109 citations in OpenAlex.

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  18. Superiority ofAnnals of nuclear medicine · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 11 institutions in 2 countries.

Laila A GharzaiDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA.
Ralph JiangDepartment of Biostatistics, University of Michigan, Ann Arbor, MI, USA.
David WallingtonDepartment of Radiation Oncology, Western Michigan University, Kalamazoo, MI, USA.
Gavin JonesDepartment of Radiation Oncology, University of Kentucky, Lexington, KY, USA.
Samuel BirerDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA.
Neil JairathDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA.
Elizabeth M JaworskiDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA.
Matthew R McFarlaneDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA.
Brandon A MahalDepartment of Radiation Oncology, University of Miami, Miami, FL, USA.
Paul L NguyenDepartment of Radiation Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Howard SandlerDepartment of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.
Todd M MorganDepartment of Urology, University of Michigan, Ann Arbor, MI, USA.
Zachery R ReichertDepartment of Medical Oncology, University of Michigan, Ann Arbor, MI, USA.
Joshi J AlumkalDepartment of Medical Oncology, University of Michigan, Ann Arbor, MI, USA.
Rohit MehraDepartment of Pathology, University of Michigan, Ann Arbor, MI, USA.
Amar U KishanDepartment of Radiation Oncology, University of California Los Angeles, Los Angeles, CA, USA.
Karim FizaziDepartment of Cancer Medicine, Institut Gustave-Roussy, Villejuif, France.
Susan HalabiDepartment of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.
Edward M SchaefferDepartment of Urology, Northwestern University, Chicago, IL, USA.
Felix Y FengDepartment of Radiation Oncology, University of California San Francisco, San Francisco, CA, USA.
David ElliottDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA.
Robert T DessDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA.
William C JacksonDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA.
Matthew J SchipperDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA; Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA.
Daniel E SprattDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA. Electronic address: sprattda@med.umich.edu.
University of Michigan–Ann Arbor · USCedars-Sinai Medical Center · USDana-Farber Cancer Institute · USDuke University · USInstitut Gustave Roussy · FRNorthwestern University · USUniversity of California, Los Angeles · USUniversity of California, San Francisco · USUniversity of Kentucky · USUniversity of Miami · USWestern Michigan University · US

Funding

Tissue/InformaticsP50CA186786 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Ganesh S Palapattu · 2014 to 2026
$27.6M
Determining the clinical impact of gene expression testing in localized prostate cancerR01CA240991 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI MORGAN, TODD M., SPRATT, DANIEL EIDELBERG · 2019 to 2024
$3.1M
NCI NIH HHS P50 CA186786NCI NIH HHS R01 CA240991
6 · The paper itself

Abstract

backgroundThe international Intermediate Clinical Endpoints in Cancer of the Prostate working group has established metastasis-free survival as a surrogate for overall survival in localised prostate cancer based on the findings of 19 predominantly radiotherapy-based trials. We sought to comprehensively assess aggregate trial-level performance of commonly reported intermediate clinical endpoints across all randomised trials in localised prostate cancer.

methodsFor this meta-analysis, we searched PubMed for all trials in localised or biochemically recurrent prostate cancer published between Jan 1, 1970, and Jan 15, 2020. Eligible trials had to be randomised, therapeutic, reporting overall survival and at least one intermediate clinical endpoint, and with a sample size of at least 70 participants. Trials of metastatic disease were excluded. Intermediate clinical endpoints included biochemical failure, local failure, distant metastases, biochemical failure-free survival, progression-free survival, and metastasis-free survival. Candidacy for surrogacy was assessed using the second condition of the meta-analytical approach (ie, correlation of the treatment effect of the intermediate clinical endpoint and overall survival), using R

findings75 trials (53 631 patients) were included in our analysis. Median follow-up was 9·1 years (IQR 5·7-10·6). Biochemical failure (R

interpretationIntermediate clinical endpoints based on biochemical and local failure did not meet the second condition of the meta-analytical approach and are not surrogate endpoints for overall survival in localised prostate cancer. Our findings validate metastasis-free survival as the only identified surrogate endpoint for overall survival to date.

fundingProstate Cancer Foundation and National Institutes of Health.

Indexed as

AgedBiomarkersCombined Modality TherapyFollow-Up StudiesHumansLymphatic MetastasisMaleNeoplasm Recurrence, LocalPrognosisProstatic NeoplasmsSurvival RateBiomarkers

Identifiers

PMID33662287
PMCPMC10949134
OpenAlexW3135666978

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.