Evidence map›Paper›PMID 30817251›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2019

Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer.

James L Gulley, Michael Borre, Nicholas J Vogelzang, Siobhan Ng, Neeraj Agarwal, Chris C Parker, David W Pook, Per Rathenborg, Thomas W Flaig, Joan Carles and 9 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2019. 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 191 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
191citing papers in PubMed, 2 pooled it
24.9field-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.

NCT06927297 phase1recruitingnot on this mapstarted 2025, after this paper: background citation

A Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Antitumor Activity of an Engineered Mitochondrial Vaccine in Treatment of Advanced Solid Tumors

TypeinterventionalSponsorWest China HospitalRan2025 to 2028Enrolled12ConditionsAdvanced Solid Tumor Malignancies, Advanced Solid MalignanciesArmsEngineered mitochondrial vaccine
NCT07572864 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

Efficacy and Safety of Immune Checkpoint Inhibitors in Combination With Engineered Mitochondrial Vaccine as Neoadjuvant and Adjuvant Therapy for Resectable Head and Neck Squamous Cell Carcinoma: A Single-Arm, Single-Center Clinical Study.

TypeinterventionalSponsorWest China HospitalRan2026 to 2028Enrolled9ConditionsHead and Neck Squamous Cell CarcinomaArmsEngineered Mitochondrial Vaccine (IMP3-Mito), Immune checkpoint inhibitor (ICI)
3 · Its place in the literature

Who cites it

191 citing papers in PubMed, 2 syntheses or guidelines pooled it, 271 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 18 institutions in 9 countries.

James L Gulley1 National Institutes of Health, Bethesda, MD.
Michael Borre2 Aarhus Universitetshospital, Åarhus, Denmark.
Nicholas J Vogelzang3 Comprehensive Cancer Centers of Nevada, Las Vegas, NV.
Siobhan Ng4 St John of God Subiaco Hospital, Subiaco, Western Australia, Australia.
Neeraj Agarwal5 University of Utah Huntsman Cancer Institute, Salt Lake City, UT.
Chris C Parker6 Royal Marsden Hospital, Sutton, United Kingdom.
David W Pook7 Monash Medical Centre, Bentleigh, Victoria, Australia.
Per Rathenborg8 Herlev Hospital, Herlev, Denmark.
Thomas W Flaig9 University of Colorado Cancer Center, Aurora, CO.
Joan Carles10 Vall d'Hebron Institute of Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.
Fred Saad11 Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada.
Neal D Shore12 Carolina Urologic Research Center, Myrtle Beach, SC.
Liddy Chen13 Bavarian Nordic, Morrisville, NC.
Christopher R Heery13 Bavarian Nordic, Morrisville, NC.
Winald R Gerritsen14 Radboudumc, Nijmegen, the Netherlands.
Frank Priou15 Centre Hospitalier Départemental, La Roche sur Yon, France.
Niels C Langkilde16 Aalborg Universitethospital, Aalborg, Denmark.
Andrey Novikov17 North-Western State Medical University, Saint Petersburg, Russia.
Philip W Kantoff18 Memorial Sloan Kettering Cancer Center, New York, NY.
National Institutes of Health · USAalborg University · DKAalborg University Hospital · DKAarhus University · DKBavarian Nordic (United States) · USCarolina Urologic Research Center · USCentre Hospitalier de l’Université de Montréal · CACentre Hospitalier Départemental Vendée · FRComprehensive Cancer Centers of Nevada · USHerlev Hospital · DKMemorial Sloan Kettering Cancer Center · USMonash Medical Centre · AUNorth-Western State Medical University named after I.I. Mechnikov · RURadboud University Nijmegen · NLRoyal Marsden Hospital · GBSt John of God Subiaco Hospital · AUUniversity of Colorado Cancer Center · USVall d'Hebron Hospital Universitari · ES

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Cancer Therapy Clinical Trials Using Novel Recombinant VaccinesZIABC010666 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2025
$22.4M
Department of HealthNCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposePROSTVAC, a viral vector-based immunotherapy, prolonged median overall survival (OS) by 8.5 months versus placebo in metastatic castration-resistant prostate cancer in a phase II study. This phase III study further investigated those findings. PATIENTS AND

methodsPatients were randomly assigned to PROSTVAC (Arm V; n = 432), PROSTVAC plus granulocyte-macrophage colony-stimulating factor (Arm VG; n = 432), or placebo (Arm P; n = 433), stratified by prostate-specific antigen (less than 50 ng/mL

resultsAt the third interim analysis, criteria for futility were met and the trial was stopped early. Neither active treatment had an effect on median OS (Arm V, 34.4 months; hazard ratio, 1.01; 95% CI, 0.84 to 1.20;

conclusionWhereas PROSTVAC was safe and well tolerated, it had no effect on OS or AWE in metastatic castration-resistant prostate cancer. Combination therapy is currently being explored in clinical trials.

Indexed as

AgedCancer VaccinesDouble-Blind MethodGranulocyte-Macrophage Colony-Stimulating FactorHLA-A2 AntigenHumansMaleNeoplasm MetastasisProstatic Neoplasms, Castration-ResistantSurvival RateCancer VaccinesGranulocyte-Macrophage Colony-Stimulating FactorHLA-A2 AntigenPROSTVAC

Identifiers

PMID30817251
PMCPMC6494360
OpenAlexW2915177933

What OpenQuestion holds

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LicenceCC BY
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.