Evidence map›Paper›PMID 20100959›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2010

Overall survival analysis of a phase II randomized controlled trial of a Poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer.

Philip W Kantoff, Thomas J Schuetz, Brent A Blumenstein, L Michael Glode, David L Bilhartz, Michael Wyand, Kelledy Manson, Dennis L Panicali, Reiner Laus, Jeffrey Schlom and 4 more

3 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 498 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
498citing papers in PubMed, 2 pooled it
45.9field-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.

NCT00078585 phase2completednot on this map

A Phase II Randomized, Double Blind, Controlled Study to Evaluate the Safety and Efficacy of PROSTVAC®-VF/TRICOM™ in Combination With GM-CSF in Patients With Androgen-Independent Adenocarcinoma of the Prostate

TypeinterventionalSponsorBavarian NordicRan2003 to 2009Enrolled120ConditionsProstate CancerArmsPROSTVAC®-VF/TRICOM™
NCT01867333 phase2completednot on this mapstarted 2013, after this paper: background citation

A Randomized Phase II Trial Combining Vaccine Therapy With PROSTVAC /TRICOM and Enzalutamide vs. Enzalutamide Alone in Men With Metastatic Castration Resistant Prostate Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2013 to 2022Enrolled57ConditionsProstate CancerArmsPROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -F/TRICOM, PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) -V/TRICOM, Enzalutamide
NCT02153918 phase2completednot on this mapstarted 2014, after this paper: background citation

A Phase II Study of Neoadjuvant rFowlpox-PSA (L155)-TRICOM (Prostvac-F/TRICOM) in Combination With rVaccinia-PSA (L155)-TRICOM (Prostvac-V/TRICOM) in Men With Prostate Cancer Undergoing Treatment With Radical Prostatectomy

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2014 to 2018Enrolled27ConditionsProstate Cancer, Prostatic Neoplasms, Neoplasms, ProstateArmsPROSTVAC-V/TRICOM, PROSTVAC-F/TRICOM
3 · Its place in the literature

Who cites it

498 citing papers in PubMed, 2 syntheses or guidelines pooled it, 969 citations in OpenAlex.

  1. Pooled it
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  4. Phase II Trial of Pembrolizumab and Anti-CD3 x Anti-HER2 Bispecific Antibody-Armed Activated T Cells in Metastatic Castration-Resistant Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
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  9. Phase III Trial of PROSTVAC in Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
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438 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 1 institution in 1 country.

Philip W KantoffMedical Director, BN ImmunoTherapeutics, 2425 Garcia Ave, Mountain View, CA 94043, USA.
Thomas J Schuetz
Brent A Blumenstein
L Michael Glode
David L Bilhartz
Michael Wyand
Kelledy Manson
Dennis L Panicali
Reiner Laus
Jeffrey Schlom
William L Dahut
Philip M Arlen
James L Gulley
Wayne R Godfrey
Dana-Farber Cancer Institute · US

Funding

Cancer Therapy Clinical Trials Using Novel Recombinant VaccinesZIABC010666 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2025
$22.4M
Strategies for Therapeutic Cancer Vaccine Clinical TrialsZIABC010425 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2009 to 2023
$13.7M
The Evaluation of Novel Therapeutics for Genitourinary MalignanciesZIASC010098 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI DAHUT, WILLIAM L. · 2009 to 2022
$7.6M
6 · The paper itself

Abstract

purposeTherapeutic prostate-specific antigen (PSA) -targeted poxviral vaccines for prostate cancer have been well tolerated. PROSTVAC-VF treatment was evaluated for safety and for prolongation of progression-free survival (PFS) and overall survival (OS) in a randomized, controlled, and blinded phase II study. PATIENTS AND

methodsIn total, 125 patients were randomly assigned in a multicenter trial of vaccination series. Eligible patients had minimally symptomatic castration-resistant metastatic prostate cancer (mCRPC). PROSTVAC-VF comprises two recombinant viral vectors, each encoding transgenes for PSA, and three immune costimulatory molecules (B7.1, ICAM-1, and LFA-3). Vaccinia-based vector was used for priming followed by six planned fowlpox-based vector boosts. Patients were allocated (2:1) to PROSTVAC-VF plus granulocyte-macrophage colony-stimulating factor or to control empty vectors plus saline injections.

resultsEighty-two patients received PROSTVAC-VF and 40 received control vectors. Patient characteristics were similar in both groups. The primary end point was PFS, which was similar in the two groups (P = .6). However, at 3 years post study, PROSTVAC-VF patients had a better OS with 25 (30%) of 82 alive versus 7 (17%) of 40 controls, longer median survival by 8.5 months (25.1 v 16.6 months for controls), an estimated hazard ratio of 0.56 (95% CI, 0.37 to 0.85), and stratified log-rank P = .0061.

conclusionPROSTVAC-VF immunotherapy was well tolerated and associated with a 44% reduction in the death rate and an 8.5-month improvement in median OS in men with mCRPC. These provocative data provide preliminary evidence of clinically meaningful benefit but need to be confirmed in a larger phase III study.

Indexed as

AgedAged, 80 and overCancer VaccinesDouble-Blind MethodGenetic VectorsHumansImmunizationMaleMiddle AgedNeoplasm MetastasisOrchiectomyPoxviridaeProstate-Specific AntigenProstatic NeoplasmsVaccines, SyntheticCancer VaccinesProstate-Specific AntigenVaccines, Synthetic

Identifiers

PMID20100959
PMCPMC2834462
OpenAlexW2155846302

What OpenQuestion holds

Textmetadata
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.