Evidence map›Paper›PMID 34423501›Full record

Trial reportThe oncologist2021

Radium-223 plus Enzalutamide Versus Enzalutamide in Metastatic Castration-Refractory Prostate Cancer: Final Safety and Efficacy Results.

Benjamin L Maughan, Adam Kessel, Taylor Ryan McFarland, Nicolas Sayegh, Roberto Nussenzveig, Andrew W Hahn, John M Hoffman, Kathyrn Morton, Deepika Sirohi, Manish Kohli and 4 more

Open access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in The oncologist, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
3.7field-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

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.

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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

14 authors at 3 institutions in 1 country.

Benjamin L Maughan *Genitourinary Oncology, Huntsman Cancer Institute, Salt Lake City, Utah, USA.
Adam Kessel *Genitourinary Oncology, Huntsman Cancer Institute, Salt Lake City, Utah, USA.
Taylor Ryan McFarlandGenitourinary Oncology, Huntsman Cancer Institute, Salt Lake City, Utah, USA.
Nicolas SayeghGenitourinary Oncology, Huntsman Cancer Institute, Salt Lake City, Utah, USA.
Roberto NussenzveigGenitourinary Oncology, Huntsman Cancer Institute, Salt Lake City, Utah, USA.
Andrew W HahnThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
John M HoffmanCenter for Quantitative Cancer Imaging, Huntsman Cancer Institute, Salt Lake City, Utah, USA.
Kathyrn MortonDepartment of Radiology and Imaging Sciences, Huntsman Cancer Institute, Salt Lake City, Utah, USA.
Deepika SirohiARUP Laboratories, University of Utah, Salt Lake City, Utah, USA.
Manish KohliGenitourinary Oncology, Huntsman Cancer Institute, Salt Lake City, Utah, USA.
Umang SwamiGenitourinary Oncology, Huntsman Cancer Institute, Salt Lake City, Utah, USA.
Kenneth BoucherGenitourinary Oncology, Huntsman Cancer Institute, Salt Lake City, Utah, USA.
Benjamin HaalandCenter for Quantitative Cancer Imaging, Huntsman Cancer Institute, Salt Lake City, Utah, USA.
Neeraj AgarwalGenitourinary Oncology, Huntsman Cancer Institute, Salt Lake City, Utah, USA.
Huntsman Cancer Institute · USThe University of Texas MD Anderson Cancer Center · USUniversity of Utah · US

Funding

Utah Center for Clinical and Translational ScienceUL1TR002538 · NCATS · UNIVERSITY OF UTAH · PI HESS, RACHEL, MAJERSIK, JENNIFER JUHL · 2018 to 2022
$26.0M
NCATS NIH HHS UL1 TR002538
6 · The paper itself

Abstract

lessons learnedLong-term safety of radium-223 with enzalutamide was confirmed in this clinical trial. PSA-PFS2 was prolonged with the combination compared with enzalutamide alone.

backgroundPreviously, we showed the combination of radium-223 and enzalutamide to be safe and associated with improved efficacy based on a concomitant decline in serum bone metabolism markers compared with enzalutamide alone in a phase II trial of men with metastatic castration-resistant prostate cancer (mCRPC) [1].

methodsSecondary endpoints were not included in our initial report, and we include them herein, after a median follow-up of 22 months. These objectives included long-term safety, prostate-specific antigen (PSA)-progression-free survival (PFS), and radiographic progression-free survival; PSA-PFS2 (time from start of protocol therapy to PSA progression on subsequent therapy); time to next therapy (TTNT); and overall survival (OS). Survival analysis and log-rank tests were performed using the R statistical package v.4.0.2 (https://www.r-project.org). Statistical significance was defined as p < .05.

resultsOf 47 patients (median age, 68 years), 35 received the combination and 12 enzalutamide alone. After a median follow-up of 22 months, final safety results did not show any increase in fractures or other adverse events in the combination arm. PSA-PFS2 was significantly improved, and other efficacy parameters were numerically improved in the combination over the enzalutamide arm.

conclusionThe combination of enzalutamide and radium-223 was found to be safe and associated with promising efficacy in men with mCRPC. These hypothesis-generating results portend well for the ongoing phase III PEACE III trial in this setting.

Indexed as

PhenylthiohydantoinProstatic NeoplasmsAgedBenzamidesCastrationHumansMaleNitrilesRadiumBenzamidesenzalutamideNitrilesPhenylthiohydantoinRadiumRadium-223EnzalutamideMetastatic castration-refractory prostate cancerRadium-223

Identifiers

PMID34423501
PMCPMC8649019
OpenAlexW3194153432

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.