Evidence map›Paper›PMID 26111351›Full record

Trial reportHuman vaccines & immunotherapeutics2015

Randomized phase II trial of docetaxel with or without PSA-TRICOM vaccine in patients with castrate-resistant metastatic prostate cancer: A trial of the ECOG-ACRIN cancer research group (E1809).

Douglas G McNeel, Yu-Hui Chen, James L Gulley, Alexander J Dwyer, Ravi A Madan, Michael A Carducci, Robert S DiPaola

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
4.1field-weighted citation impact, top 6% 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

19 citing papers in PubMed, 29 citations in OpenAlex.

  1. Review
  2. Vaccines as treatments for prostate cancer.Nature reviews. Urology · 2023
    Review
  3. Review
  4. Review
  5. WHSC1/NSD2 regulates immune infiltration in prostate cancer.Journal for immunotherapy of cancer · 2021
    Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. New drugs in prostate cancer.Prostate international · 2016
    Review
  15. Article
  16. Review
  17. Article
  18. Immunotherapy for prostate cancer enters its golden age.Clinical Medicine Insights. Oncology · 2012
    Article
  19. 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

7 authors at 4 institutions in 1 country.

Douglas G McNeela University of Wisconsin Carbone Cancer Center ; Madison , WI USA.
Yu-Hui Chenb Dana Farber Cancer Institute ; Boston , MA USA.
James L Gulleyc National Cancer Institute ; Bethesda , MD USA.
Alexander J Dwyera University of Wisconsin Carbone Cancer Center ; Madison , WI USA.
Ravi A Madanc National Cancer Institute ; Bethesda , MD USA.
Michael A Carduccid Johns Hopkins University School of Medicine ; Baltimore , MD USA.
Robert S DiPaolae Rutgers Cancer Institute of New Jersey ; New Brunswick , NJ USA.
University of Wisconsin Carbone Cancer Center · USDana-Farber Cancer Institute · USJohns Hopkins Medicine · USRutgers Cancer Institute of New Jersey

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO · 2014 to 2026
$111.2M
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
Institutional Clinical and Translational Science AwardUL1TR000427 · NCATS · UNIVERSITY OF WISCONSIN-MADISON · PI DREZNER, MARC KENNETH · 2012 to 2016
$32.2M
Clinical trials employing cancer vaccine combination therapiesZIABC010945 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GULLEY, JAMES L. · 2009 to 2022
$9.6M
NCTN LAPS at Johns HopkinsUG1CA233196 · NCI · JOHNS HOPKINS UNIVERSITY · PI DEBORAH K ARMSTRONG, Julie Renee Brahmer · 2019 to 2026
$4.6M
Johns Hopkins University NCTN Lead Academic Site ProgramU10CA180802 · NCI · JOHNS HOPKINS UNIVERSITY · PI ARMSTRONG, DEBORAH K, BRAHMER, JULIE RENEE · 2014 to 2018
$3.3M
National Clinical Trials Network Research at the University of WisconsinU10CA180799 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI ANDERSON, BETHANY M, KUSHNER, DAVID M · 2014 to 2018
$2.8M
NCATS NIH HHS UL1 TR000427NCI NIH HHS CA180794NCI NIH HHS CA180799NCI NIH HHS CA180802NCI NIH HHS CA180820NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA066636NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180802NCI NIH HHS U10 CA180820NCI NIH HHS U24 CA196172NCI NIH HHS UG1 CA233196
6 · The paper itself

Abstract

unlabelledAnti-tumor vaccines have demonstrated efficacy in patients with castration-resistant metastatic prostate cancer. One vaccine, Prostvac-VF®, using a heterologous prime-boost strategy with vaccinia and fowlpox viral vectors encoding PSA, is currently being evaluated in a registration phase III multinational clinical trial. The current trial was planned to assess the clinical efficacy of this vaccine in patients with castration-resistant metastatic prostate cancer receiving subsequent docetaxel chemotherapy. 10 patients with metastatic castration-resistant prostate cancer, with a predicted survival of at least 18 months, were enrolled out of a planned 144 patients. Eight of 10 patients were treated and were randomized to receive docetaxel chemotherapy alone (Arm B, n = 2) versus treatment with Prostvac-VF (days 1, 15, 29, 43, 57) followed by docetaxel (Arm A, n = 6) chemotherapy beginning at month 3. The primary endpoint of the trial was overall survival, and secondary endpoints included time to radiographic progression and immunological response. The trial was opened within the Eastern Cooperative Oncology Group, but due to slow accrual was closed by CTEP after only 10 patients were enrolled within 13 months.

resultsPresented here are the safety, clinical, and immunological results from 8 eligible patients who underwent treatment. Two of 6 patients treated on Arm A, with vaccine followed by docetaxel, had a >50% PSA response, with one of these patients experiencing a PSA decline during treatment with vaccine. Significant PSA-specific CD4+ and CD8+ T-cell responses and IgG antibody responses specific for PSA were not detected. The primary endpoint of overall survival cannot be assessed due to limited accrual. The lack of T-cell responses, even in this small cohort, suggests that further validation and development of immune biomarkers will be important for future studies. Other trials remain ongoing to evaluate the role of anti-tumor vaccination in sequence with other traditional anti-tumor therapies.

Indexed as

AgedAntibodies, NeoplasmAntineoplastic AgentsCancer VaccinesCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesDocetaxelHumansImmunoglobulin GMaleMiddle AgedNeoplasm MetastasisProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantSurvival AnalysisTaxoidsAntibodies, NeoplasmAntineoplastic AgentsCancer VaccinesDocetaxelImmunoglobulin GProstate-Specific AntigenPROSTVACTaxoidsdocetaxelphase II clinical trialprostate cancervaccine

Identifiers

PMID26111351
PMCPMC4635940
OpenAlexW1940135647

What OpenQuestion holds

Textmetadata
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.