Evidence map›Paper›PMID 33617303›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

TRANSFORMER: A Randomized Phase II Study Comparing Bipolar Androgen Therapy Versus Enzalutamide in Asymptomatic Men With Castration-Resistant Metastatic Prostate Cancer.

Samuel R Denmeade, Hao Wang, Neeraj Agarwal, David C Smith, Michael T Schweizer, Mark N Stein, Vasileios Assikis, Przemyslaw W Twardowski, Thomas W Flaig, Russell Z Szmulewitz and 18 more

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

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 79 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
79citing papers in PubMed, 2 pooled it
15.6field-weighted citation impact, top 1% 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

79 citing papers in PubMed, 2 syntheses or guidelines pooled it, 134 citations in OpenAlex.

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  13. Lack of synergy between AR-targeted therapies and PARP inhibitors in homologous recombination-proficient prostate cancer.Proceedings of the National Academy of Sciences of the United States of America · 2026
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19 more citing papers are in PubMed but not listed here.

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

28 authors at 17 institutions in 1 country.

Samuel R DenmeadeThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.ORCID 0000-0001-5442-515X
Hao WangThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.
Neeraj AgarwalThe Huntsman Cancer Institute, Salt Lake City, UT.ORCID 0000-0003-1076-0428
David C SmithThe University of Michigan, Ann Arbor, MI.ORCID 0000-0002-9465-988X
Michael T SchweizerThe University of Washington, Seattle, WA.ORCID 0000-0002-5510-0661
Mark N SteinRutgers University, New Brunswick, NJ.ORCID 0000-0002-0853-3640
Vasileios AssikisPiedmont Cancer Institute, Atlanta, GA.
Przemyslaw W TwardowskiCity of Hope Cancer Center, Duarte, CA.
Thomas W FlaigUniversity of Colorado, Aurora, CO.ORCID 0000-0001-6145-9040
Russell Z SzmulewitzUniversity of Chicago, Chicago, IL.
Jeffrey M HolzbeierleinUniversity of Kansas, Kansas City, KA.
Ralph J HaukeNebraska Cancer Specialists, Omaha, NE.
Guru SonpavdeUniversity of Alabama at Birmingham, Birmingham, AL.ORCID 0000-0002-1010-9611
Jorge A GarciaThe Cleveland Clinic, Cleveland, OH.
Arif HussainThe University of Maryland, Baltimore, MD.ORCID 0000-0001-8485-4406
Oliver SartorTulane University, New Orleans, LA.ORCID 0000-0002-8777-7343
Shifeng MaoAllegheny General Hospital, Pittsburgh, PA.ORCID 0000-0001-9532-0303
Harry CaoThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.
Wei FuThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.
Ting WangThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.
Rehab AbdallahThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.
Su Jin LimThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.
Vanessa BolejackCancer Research and Biostatistics, Seattle, WA.ORCID 0000-0003-2118-8500
Channing J PallerThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.ORCID 0000-0003-3658-1858
Michael A CarducciThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.
Mark C MarkowskiThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.ORCID 0000-0003-2780-5100
Mario A EisenbergerThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.ORCID 0000-0002-8787-3271
Emmanuel S AntonarakisThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.ORCID 0000-0003-0031-9655
Sidney Kimmel Comprehensive Cancer Center · USAllegheny General Hospital · USCancer Research And Biostatistics · USCity of Hope · USCleveland Clinic · USHuntsman Cancer Institute · USNebraska Cancer Specialists · USPiedmont Cancer Institute · USRutgers, The State University of New Jersey · USTulane University · USUniversity of Alabama at Birmingham · USUniversity of Chicago · USUniversity of Colorado Anschutz Medical Campus · USUniversity of Kansas · USUniversity of Maryland, Baltimore · USUniversity of Michigan · USUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeProstate cancer (PCa) becomes resistant to androgen ablation through adaptive upregulation of the androgen receptor in response to the low-testosterone microenvironment. Bipolar androgen therapy (BAT), defined as rapid cycling between high and low serum testosterone, disrupts this adaptive regulation in castration-resistant PCa (CRPC).

methodsThe TRANSFORMER (Testosterone Revival Abolishes Negative Symptoms, Fosters Objective Response and Modulates Enzalutamide Resistance) study is a randomized study comparing monthly BAT (n = 94) with enzalutamide (n = 101). The primary end point was clinical or radiographic progression-free survival (PFS); crossover was permitted at progression. Secondary end points included overall survival (OS), prostate-specific antigen (PSA) and objective response rates, PFS from randomization through crossover (PFS2), safety, and quality of life (QoL).

resultsThe PFS was 5.7 months for both arms (hazard ratio [HR], 1.14; 95% CI, 0.83 to 1.55;

conclusionThis randomized trial establishes meaningful clinical activity and safety of BAT and supports additional study to determine its optimal clinical integration. BAT can sensitize CRPC to subsequent antiandrogen therapy. Further study is required to confirm whether sequential therapy with BAT and enzalutamide can improve survival in men with CRPC.

Indexed as

AgedAged, 80 and overAsymptomatic DiseasesBenzamidesCross-Over StudiesHumansMaleMiddle AgedNeoplasm MetastasisNitrilesPhenylthiohydantoinProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantQuality of LifeReceptors, AndrogenTestosteroneBenzamidesenzalutamideNitrilesPhenylthiohydantoinProstate-Specific AntigenReceptors, AndrogenTestosteronetestosterone 17 beta-cypionate

Identifiers

PMID33617303
PMCPMC8274807
OpenAlexW3133300324

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.