Evidence map›Paper›PMID 36367998›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023

Phase II Randomized Study of Salvage Radiation Therapy Plus Enzalutamide or Placebo for High-Risk Prostate-Specific Antigen Recurrent Prostate Cancer After Radical Prostatectomy: The SALV-ENZA Trial.

Phuoc T Tran, Kathryn Lowe, Hua-Ling Tsai, Daniel Y Song, Arthur Y Hung, Jason W D Hearn, Steven Miller, James A Proudfoot, Matthew P Deek, Ryan Phillips and 21 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02203695 (Phase II Randomized Placebo-Controlled Double-Blind Study of Salvage Radiation Therapy), which is not on this map. Cited by 22 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 4 pooled it
5.3field-weighted citation impact, top 3% 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.

NCT02203695 phase2completednot on this map

Phase II Randomized Placebo-Controlled Double-Blind Study of Salvage Radiation Therapy (SRT) Plus Placebo Versus SRT Plus Enzalutamide in Men With High-Risk PSA-Recurrent Prostate Cancer After Radical Prostatectomy

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2015 to 2022Enrolled86ConditionsAdenocarcinoma of the ProstateArmsEnzalutamide, SRT
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 4 syntheses or guidelines pooled it, 37 citations in OpenAlex.

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  5. Androgen receptor pathway inhibitor intensification in non-metastatic hormone-sensitive prostate cancer: current evidence and clinical implications.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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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

31 authors at 12 institutions in 1 country.

Phuoc T TranDepartment of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0002-0147-0376
Kathryn LoweDepartment of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.
Hua-Ling TsaiDepartment of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.
Daniel Y SongDepartment of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.
Arthur Y HungDepartment of Radiation Medicine, OHSU Knight Cancer Institute, Oregon Health & Science University, Portland, OR.
Jason W D HearnDepartment of Radiation Oncology, University of Michigan, Ann Arbor, MI.ORCID 0000-0003-4099-1403
Steven MillerKarmanos Cancer Institute, Department of Oncology, Wayne State University School of Medicine, Detroit, MI.
James A ProudfootVeracyte, San Diego, CA.
Matthew P DeekDepartment of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0002-5949-5058
Ryan PhillipsDepartment of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0003-4895-9838
Tamara LotanDepartment of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.
Channing J PallerDepartment of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0003-3658-1858
Catherine H MarshallDepartment of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0002-2653-4110
Mark MarkowskiDepartment of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0003-2780-5100
Shirl DipasqualeDepartment of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.
Samuel DenmeadeDepartment of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0001-5442-515X
Michael CarducciDepartment of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.
Mario EisenbergerDepartment of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0002-8787-3271
Theodore L DeWeeseDepartment of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.
Matthew OrtonDepartment of Radiation Oncology, Indiana University Health Arnett, Lafayette, IN.
Curtiland DevilleDepartment of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0003-4846-6486
Elai DavicioniVeracyte, San Diego, CA.ORCID 0000-0001-9136-099X
Stanley L LiauwDepartment of Radiation Oncology and Cellular Oncology, University of Chicago, Chicago, IL.ORCID 0000-0002-4701-2469
Elisabeth I HeathKarmanos Cancer Institute, Department of Oncology, Wayne State University School of Medicine, Detroit, MI.ORCID 0000-0003-1381-2713
Stephen GrecoDepartment of Radiation Oncology & Molecular Radiation Sciences, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.
Neil B DesaiDepartment of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas, TX.
Daniel E SprattDepartment of Radiation Oncology, University Hospitals Seidman Cancer Center, Cleveland, OH.ORCID 0000-0002-5973-4741
Felix FengDepartments of Medicine, Radiation Oncology and Urology, University of California San Francisco, San Francisco, CA.ORCID 0000-0002-0963-7687
Hao WangDepartment of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.
Tomasz M BeerOHSU Knight Cancer Institute, Oregon Health & Science University, Portland, OR.ORCID 0000-0001-5600-9993
Emmanuel S AntonarakisDepartment of Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0003-0031-9655
Johns Hopkins University · USOregon Health & Science University · USVeracyte (United States) · USWayne State University · USIndiana University Health · USThe University of Texas Southwestern Medical Center · USUniversity Hospitals Seidman Cancer Center · USUniversity of California, San Francisco · USUniversity of Chicago · USUniversity of Maryland, Baltimore · USUniversity of Michigan · USUniversity of Minnesota · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
Resource Sharing CoreU54CA273956 · NCI · UNIVERSITY OF MARYLAND BALTIMORE · PI Phuoc T. Tran · 2022 to 2026
$8.9M
Tumor-barcoding coupled with high-throughput sequencing of a novel chemoradiation resistant SCLC mouse modelU01CA231776 · NCI · JOHNS HOPKINS UNIVERSITY · PI HANN, CHRISTINE L., MARCHIONNI, LUIGI · 2018 to 2022
$3.9M
Integrating bioinformatics into multiscale models for hepatocellular carcinomaU01CA212007 · NCI · JOHNS HOPKINS UNIVERSITY · PI EWALD, ANDREW JOSEF, FERTIG, ELANA · 2018 to 2022
$3.2M
NCI NIH HHS P30 CA006973NCI NIH HHS U01 CA212007NCI NIH HHS U01 CA231776NCI NIH HHS U54 CA273956
6 · The paper itself

Abstract

purposeWe sought to investigate whether enzalutamide (ENZA), without concurrent androgen deprivation therapy, increases freedom from prostate-specific antigen (PSA) progression (FFPP) when combined with salvage radiation therapy (SRT) in men with recurrent prostate cancer after radical prostatectomy (RP). PATIENTS AND

methodsMen with biochemically recurrent prostate cancer after RP were enrolled into a randomized, double-blind, phase II, placebo-controlled, multicenter study of SRT plus ENZA or placebo (ClinicalTrials.gov identifier: NCT02203695). Random assignment (1:1) was stratified by center, surgical margin status (R0

resultsEighty-six (86) patients were randomly assigned, with a median follow-up of 34 (range, 0-52) months. Trial arms were well balanced. The median pre-SRT PSA was 0.3 (range, 0.06-4.6) ng/mL, 56 of 86 patients (65%) had extraprostatic disease (pT3), 39 of 86 (45%) had a Gleason sum of 8-10, and 43 of 86 (50%) had positive surgical margins (R1). FFPP was significantly improved with ENZA versus placebo (hazard ratio [HR], 0.42; 95% CI, 0.19 to 0.92;

conclusionSRT plus ENZA monotherapy for 6 months in men with PSA-recurrent high-risk prostate cancer after RP is safe and delays PSA progression relative to SRT alone. The impact of ENZA on distant metastasis or survival is unknown at this time.

Indexed as

Prostate-Specific AntigenProstatic NeoplasmsAndrogen AntagonistsBenzamidesHumansMaleNeoplasm Recurrence, LocalNitrilesPhenylthiohydantoinProstateProstatectomySalvage TherapyAndrogen AntagonistsBenzamidesenzalutamideNitrilesPhenylthiohydantoinProstate-Specific Antigen

Identifiers

PMID36367998
PMCPMC9940936
OpenAlexW4308835030

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.