Evidence map›Paper›PMID 33451978›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2021

Randomized Phase II Trial of Sipuleucel-T with or without Radium-223 in Men with Bone-metastatic Castration-resistant Prostate Cancer.

Catherine H Marshall, Wei Fu, Hao Wang, Jong Chul Park, Theodore L DeWeese, Phuoc T Tran, Daniel Y Song, Serina King, Michaella Afful, Julia Hurrelbrink and 9 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02463799 (A Phase 2 Study of Sipuleucel-T With or Without Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-Metastatic Castrate-Resistant Prostate Cancer), which is not on this map. Cited by 46 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 3 pooled it
7.0field-weighted citation impact, top 2% 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.

NCT02463799 phase2completednot on this map

A Phase 2 Study of Sipuleucel-T With or Without Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-Metastatic Castrate-Resistant Prostate Cancer

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2016 to 2019Enrolled36ConditionsProstate CancerArmsRadium-223, Sipuleucel-T
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 3 syntheses or guidelines pooled it, 62 citations in OpenAlex.

  1. Pooled it
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  3. Pooled it
  4. Trial
  5. A Phase Ib Study of Atezolizumab with Radium-223 Dichloride in Men with Metastatic Castration-Resistant Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Trial
  6. Molecular Mechanisms and Immune Regulation in Prostate Cancer: A Review.International journal of molecular sciences · 2026
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 6 institutions in 2 countries.

Catherine H MarshallSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.ORCID 0000-0002-2653-4110
Wei FuSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.
Hao WangSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.
Jong Chul ParkMassachusetts General Hospital, Boston, Massachusetts.ORCID 0000-0002-1052-0734
Theodore L DeWeeseSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.
Phuoc T TranSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.
Daniel Y SongSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.
Serina KingSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.
Michaella AffulSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland.
Julia HurrelbrinkDuke Cancer Institute Center for Prostate and Urologic Cancer, Duke University, Durham, North Carolina.
Charlotte ManogueTulane Cancer Center, New Orleans, Louisiana.
Patrick CotognoTulane Cancer Center, New Orleans, Louisiana.
Nancy P MoldawerUrologic Oncology Program, Cedars Sinai Cancer & Cedars-Sinai Medical Center, Los Angeles, California.
Pedro C BarataTulane Cancer Center, New Orleans, Louisiana.ORCID 0000-0002-8890-2951
Charles G DrakeNew York-Presbyterian/Columbia University Medical Center, New York, NY.
Edwin M PosadasUrologic Oncology Program, Cedars Sinai Cancer & Cedars-Sinai Medical Center, Los Angeles, California.ORCID 0000-0001-8649-1346
Andrew J ArmstrongDuke Cancer Institute Center for Prostate and Urologic Cancer, Duke University, Durham, North Carolina.ORCID 0000-0001-7012-1754
Oliver SartorTulane Cancer Center, New Orleans, Louisiana.ORCID 0000-0002-8777-7343
Emmanuel S AntonarakisSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland. eantona1@jhmi.edu.
Sidney Kimmel Comprehensive Cancer Center · USLouisiana Cancer Research Center · USCedars-Sinai Medical Center · USProstate Cancer Research · GBHarvard University · USNewYork–Presbyterian Hospital · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
Tracking & Evaluation CoreU54GM104940 · NIGMS · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · PI JUDD E SHELLITO · 2012 to 2026
$69.1M
NCI NIH HHS P30 CA006973NIGMS NIH HHS U54 GM104940
6 · The paper itself

Abstract

purposeTo investigate whether radium-223 increases peripheral immune responses to sipuleucel-T in men with bone-predominant, minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND

methodsA total of 32 patients were randomized 1:1 in this open-label, phase II multicenter trial. Patients in the control arm received three sipuleucel-T treatments, 2 weeks apart. Those in the combination arm received six doses of radium-223 monthly, with sipuleucel-T intercalated between the second and fourth doses of radium-223. The primary endpoint was a comparison of peripheral antigen PA2024-specific T-cell responses (measured by proliferation index). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and PSA responses.

resultsWe enrolled 32 patients, followed for a median of 1.6 years. Six weeks after the first sipuleucel-T dose, participants in the control arm had a 3.2-fold greater change in PA2024-specific T-cell responses compared with those who received combination treatment (

conclusionsOur data raise the possibility of greater clinical activity with the combination of sipuleucel-T and radium-223 in men with asymptomatic bone mCRPC, despite the paradoxically lower immune responses observed. Additional study to confirm these findings in a larger trial is warranted.

Indexed as

AgedAged, 80 and overChemoradiotherapyFollow-Up StudiesHumansMaleMiddle AgedPrognosisProstatic Neoplasms, Castration-ResistantRadiumSurvival RateTissue ExtractsRadiumRadium-223sipuleucel-TTissue Extracts

Identifiers

PMID33451978
PMCPMC8121020
OpenAlexW3121766892

What OpenQuestion holds

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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.