Evidence map›Paper›PMID 37134294›Full record

Trial reportThe oncologist2023

Flutamide With or Without PROSTVAC in Non-metastatic Castration Resistant (M0) Prostate Cancer.

Ravi A Madan, Marijo Bilusic, Mark N Stein, Renee N Donahue, Philip M Arlen, Fatima Karzai, Elizabeth Plimack, Yu-Ning Wong, Daniel M Geynisman, Matthew Zibelman and 11 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00450463 (A Randomized Phase II Trial Combining Vaccine Therapy With PROSTVAC/TRICOM and Flutamide vs. Flutamide Alone in Men With Androgen Insensitive, Non-Metastatic), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT00450463 phase2completednot on this map

A Randomized Phase II Trial Combining Vaccine Therapy With PROSTVAC/TRICOM and Flutamide vs. Flutamide Alone in Men With Androgen Insensitive, Non-Metastatic (D0.5) Prostate Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2007 to 2017Enrolled64ConditionsProstate CancerArmsSargramostim (GM-CSF, Leukine), Flutamide (Eulexin), PROSTVAC-F/ TRICOM, PROSTVAC-V/TRICOM
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
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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

21 authors at 4 institutions in 1 country.

Ravi A MadanNational Cancer Institute, Bethesda, MD, USA.
Marijo BilusicNational Cancer Institute, Bethesda, MD, USA.
Mark N SteinDivision of Hematology/Oncology, Columbia University Medical Center, New York, NY, USA.
Renee N DonahueNational Cancer Institute, Bethesda, MD, USA.
Philip M ArlenNational Cancer Institute, Bethesda, MD, USA.
Fatima KarzaiNational Cancer Institute, Bethesda, MD, USA.
Elizabeth PlimackDepartment of Hematology/Oncology, Fox Chase Cancer Center-Temple University Health System, Philadelphia, PA, USA.
Yu-Ning WongNational Cancer Institute, Bethesda, MD, USA.
Daniel M GeynismanDepartment of Hematology/Oncology, Fox Chase Cancer Center-Temple University Health System, Philadelphia, PA, USA.
Matthew ZibelmanDepartment of Hematology/Oncology, Fox Chase Cancer Center-Temple University Health System, Philadelphia, PA, USA.
Tina MayerRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Julius StraussNational Cancer Institute, Bethesda, MD, USA.ORCID 0000-0002-7550-4938
Gang ChenNational Cancer Institute, Bethesda, MD, USA.
Myrna RauckhorstNational Cancer Institute, Bethesda, MD, USA.
Sheri McMahonNational Cancer Institute, Bethesda, MD, USA.
Anna CouvillonNational Cancer Institute, Bethesda, MD, USA.
Seth SteinbergNational Cancer Institute, Bethesda, MD, USA.
William D FiggNational Cancer Institute, Bethesda, MD, USA.
William L DahutNational Cancer Institute, Bethesda, MD, USA.
Jeffrey SchlomNational Cancer Institute, Bethesda, MD, USA.ORCID 0000-0001-7932-4072
James L GulleyNational Cancer Institute, Bethesda, MD, USA.
National Cancer Institute · USFox Chase Cancer Center · USColumbia University Irving Medical Center · USRutgers, The State University of New Jersey · US

Funding

Human T Cell Responses to Tumor Antigens for Cancer Vaccine DevelopmentZIABC010598 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2009 to 2025
$19.3M
Strategies for Therapeutic Cancer Vaccine Clinical TrialsZIABC010425 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SCHLOM, JEFFREY · 2009 to 2023
$13.7M
Drug Development for Prostate Cancer and other Metastatic ProcessesZIABC010547 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2009 to 2025
$10.2M
Cancer Immunotherapy Clinical TrialsZIABC011547 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI STRAUSS, JULIUS · 2014 to 2023
$8.1M
6 · The paper itself

Abstract

backgroundBefore 2018, there was no standard of care for non-metastatic (M0) castration resistant prostate cancer nmCRPC. Androgen receptor antagonists (ARAs) were commonly used sequentially nmCRPC.

methodsThis was a multicenter, randomized clinical trial comparing the ARA flutamide+/-PROSTVAC, a pox viral vaccine targeting PSA that includes T-cell co-stimulatory molecules. Eligible men had negative CT and Tc99 bone scans, and rising PSA on ADT. Previous treatment with ARA was a stratification factor. Patients were also evaluated for antigen-specific immune responses using intracellular cytokine staining.

resultsThirty-three patients randomized to flutamide and 31 to flutamide+vaccine. The median age was 71.8 and 69.8 years, respectively. The median time to treatment failure after a median potential follow-up of 46.7 months was, 4.5 months (range 2-70) for flutamide alone vs. 6.9 months (2.5-40; P = .38) with flutamide+vaccine. Seven patients in each arm had a >50% PSA response. Antigen-specific responses were similar in both arms (58% of patients in flutamide alone and 56% in flutamide+vaccine). The treatments were well tolerated. The most common side effect > grade 2 was injection site reaction seen in 29/31 vaccine patients which were self-limiting.

conclusionThe combination of flutamide+PROSTVAC did not improve outcomes in men with nmCRPC compared with flutamide alone. (ClinicalTrials.gov Identifier: NCT00450463).

Indexed as

Prostatic NeoplasmsProstatic Neoplasms, Castration-ResistantAndrogen AntagonistsCancer VaccinesCastrationFlutamideHumansMaleProstate-Specific AntigenAndrogen AntagonistsCancer VaccinesFlutamideProstate-Specific AntigenPROSTVACanti-androgen therapycancer vaccineimmunotherapyprostate cancer

Identifiers

PMID37134294
PMCPMC10322134
OpenAlexW4368360716

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.