Evidence map›Paper›PMID 32513836›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2020

Multicenter Phase I Trial of a DNA Vaccine Encoding the Androgen Receptor Ligand-binding Domain (pTVG-AR, MVI-118) in Patients with Metastatic Prostate Cancer.

Christos E Kyriakopoulos, Jens C Eickhoff, Anna C Ferrari, Michael T Schweizer, Ellen Wargowski, Brian M Olson, Douglas G McNeel

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02411786 (A Phase I Study of a DNA Vaccine Encoding Androgen Receptor Ligand-Binding Domain), which is not on this map. Cited by 50 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 5% 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.

NCT02411786 phase1completednot on this map

A Phase I Study of a DNA Vaccine Encoding Androgen Receptor Ligand-Binding Domain (AR LBD), With or Without Granulocyte Macrophage Colony-Stimulating Factor Adjuvant, in Patients With Metastatic Prostate Cancer

TypeinterventionalSponsorUniversity of Wisconsin, MadisonRan2015 to 2020Enrolled40ConditionsProstate CancerArmspTVG-AR, gm-csf
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.

  1. Pooled it
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  7. Review
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  14. DNA-based immunotherapy for cancer: In vivo approaches for recalcitrant targets.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
    Review
  15. Review
  16. Review
  17. Review
  18. Advances in nucleic acid-based cancer vaccines.Journal of biomedical science · 2025
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 1 country.

Christos E KyriakopoulosUniversity of Wisconsin Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin.ORCID 0000-0002-6452-7405
Jens C EickhoffUniversity of Wisconsin Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin.
Anna C FerrariDepartment of Oncology, Albert Einstein College of Medicine, Montefiore Medical Center for Cancer Care, New York, New York.
Michael T SchweizerUniversity of Washington/Fred Hutchinson Cancer Research Center, Seattle, Washington.
Ellen WargowskiUniversity of Wisconsin Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin.
Brian M OlsonEmory University, Atlanta, Georgia.
Douglas G McNeelUniversity of Wisconsin Carbone Cancer Center, University of Wisconsin-Madison, Madison, Wisconsin. dm3@medicine.wisc.edu.
University of Wisconsin Carbone Cancer Center · USEmory University · USFred Hutch Cancer Center · USMontefiore Medical Center · USUniversity of Wisconsin–Madison · US

Funding

UW COMPREHENSIVE CANCER CENTER SUPPORTP30CA014520 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI Christian Capitini · 1985 to 2026
$142.6M
Effective Anti-Tumor Vaccination - Targeting Checkpoint Regulation at the Time of T-cell ActivationR01CA219154 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI MCNEEL, DOUGLAS G. · 2017 to 2021
$1.7M
Androgen Receptor Targeted Vaccines for Prostate CancerR01CA142608 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI MCNEEL, DOUGLAS G. · 2010 to 2014
$1.6M
NCI NIH HHS P30 CA014520NCI NIH HHS R01 CA142608NCI NIH HHS R01 CA219154
6 · The paper itself

Abstract

purposePreclinical studies demonstrated that a DNA vaccine (pTVG-AR, MVI-118) encoding the androgen receptor ligand-binding domain (AR LBD) augmented antigen-specific CD8 PATIENTS AND

methodsPatients with metastatic castration-sensitive prostate cancer (mCSPC) who had recently begun androgen deprivation therapy were randomly assigned to receive pTVG-AR on one of two treatment schedules over one year, and with or without GM-CSF as a vaccine adjuvant. Patients were followed for 18 months. Primary objectives were safety and immune response. Secondary objectives included median time to PSA progression, and 18-month PSA-PFS (PPFS).

resultsForty patients were enrolled at three centers. Twenty-seven patients completed treatment and 18 months of follow-up. Eleven patients (28%) had a PSA progression event before the 18-month time point. No grade 3 or 4 adverse events were observed. Of 30 patients with samples available for immune analysis, 14 (47%) developed Th1-type immunity to the AR LBD, as determined by IFNγ and/or granzyme B ELISPOT. Persistent IFNγ immune responses were observed irrespective of GM-CSF adjuvant. Patients who developed T-cell immunity had a significantly prolonged PPFS compared with patients without immunity (HR = 0.01; 95% CI, 0.0-0.21;

conclusionspTVG-AR was safe and immunologically active in patients with mCSPC. Association between immunity and PPFS suggests that treatment may delay the time to castration resistance, consistent with preclinical findings, and will be prospectively evaluated in future trials.

Indexed as

AgedAndrogen AntagonistsCD8-Positive T-LymphocytesHumansInterferon-gammaLigandsMaleMiddle AgedNeoplasm MetastasisProgression-Free SurvivalProstate-Specific AntigenProstatic NeoplasmsProtein BindingReceptors, AndrogenVaccines, DNAAndrogen AntagonistsIFNG protein, humanInterferon-gammaLigandsProstate-Specific AntigenReceptors, AndrogenVaccines, DNA

Identifiers

PMID32513836
PMCPMC7541575
OpenAlexW3033457401

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.