Evidence map›Paper›PMID 32624280›Full record

Trial reportEuropean urology2021

A Multicohort Open-label Phase II Trial of Bipolar Androgen Therapy in Men with Metastatic Castration-resistant Prostate Cancer (RESTORE): A Comparison of Post-abiraterone Versus Post-enzalutamide Cohorts.

Mark C Markowski, Hao Wang, Rana Sullivan, Irina Rifkind, Victoria Sinibaldi, Michael T Schweizer, Benjamin A Teply, Nduku Ngomba, Wei Fu, Michael A Carducci and 6 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European urology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02090114 (A Phase II Study to Determine Sequential Response to Bipolar Androgen Therapy), which is not on this map. Cited by 54 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 1 pooled it
5.9field-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.

NCT02090114 phase2completednot on this map

A Phase II Study to Determine Sequential Response to Bipolar Androgen Therapy (BAT) Followed by Enzalutamide or Abiraterone Post-BAT in Men With Prostate Cancer Progressing on Combined Androgen Ablative Therapies

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2014 to 2021Enrolled112ConditionsProstate CancerArmsTestosterone cypionate, Testosterone Enanthate, Abiraterone acetate, Enzalutamide
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 1 synthesis or guideline pooled it, 82 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

16 authors at 3 institutions in 1 country.

Mark C MarkowskiDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA. Electronic address: mmarko12@jhmi.edu.
Hao WangDepartment of Biostatistics, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Rana SullivanDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Irina RifkindDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Victoria SinibaldiDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Michael T SchweizerDepartment of Medicine, Division of Oncology, University of Washington, Seattle, WA, USA.
Benjamin A TeplyDepartment of Internal Medicine, Division of Hematology/Oncology, University of Nebraska Medical Center, Omaha, NE, USA.
Nduku NgombaDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Wei FuDepartment of Biostatistics, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Michael A CarducciDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Channing J PallerDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Catherine H MarshallDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Mario A EisenbergerDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Jun LuoDepartment of Urology, Brady Urological Institute, Johns Hopkins University, Baltimore, MD, USA.
Emmanuel S AntonarakisDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Samuel R DenmeadeDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Johns Hopkins University · USUniversity of Nebraska Medical Center · USUniversity of Washington · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
Bipolar Androgen Therapy for Progressive Castrate Resistant Prostate CancerR01CA184012 · NCI · JOHNS HOPKINS UNIVERSITY · PI DENMEADE, SAMUEL R · 2014 to 2018
$1.3M
NCI NIH HHS P30 CA006973NCI NIH HHS R01 CA184012
6 · The paper itself

Abstract

backgroundCyclic high-dose testosterone injections, also known as bipolar androgen therapy (BAT), is a novel treatment strategy for patients with metastatic castration-resistant prostate cancer (mCRPC). BAT has shown clinical activity in prior studies enrolling men with mCRPC and may potentially restore sensitivity to prior androgen receptor (AR)-targeted agents.

objectiveTo evaluate the clinical activity of BAT in patients progressing on AR-targeted therapy as well as responses to abiraterone or enzalutamide upon rechallenge after BAT. DESIGN, SETTING, AND

participantsRESTORE is a multicohort phase II study enrolling asymptomatic mCRPC patients after abiraterone or enzalutamide at Johns Hopkins Hospital (NCT02090114). Participants (29 after abiraterone and 30 after enzalutamide) received 400 mg testosterone cypionate intramuscularly every 28 days, with ongoing luteinizing hormone-releasing hormone agonist/antagonist treatment (ie, BAT). Following progression on BAT, patients were rechallenged with their most recent AR-targeted therapy. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Coprimary endpoints were >50% decline in PSA from baseline (PSA RESULTS AND LIMITATIONS: No statistically significant difference in PSA

conclusionsBAT shows clinical activity in mCRPC patients and may be more effective at resensitizing to enzalutamide versus abiraterone. PATIENT SUMMARY: BAT is well tolerated in metastatic castration-resistant prostate cancer patients. The type of prior AR-targeted therapy might affect response to BAT as well as AR-therapy rechallenge. BAT followed by AR-targeted therapy rechallenge did not improve outcomes in AR-V7-positive patients.

Indexed as

Prostatic Neoplasms, Castration-ResistantAndrogensAndrostenesBenzamidesHumansMaleNitrilesPhenylthiohydantoinProstate-Specific AntigenReceptors, AndrogenTestosteroneabirateroneAndrogensAndrostenesBenzamidesenzalutamideNitrilesPhenylthiohydantoinProstate-Specific AntigenReceptors, AndrogenTestosteroneAndrogen receptor–targeted therapyBipolar androgen therapyTestosterone

Identifiers

PMID32624280
PMCPMC7775877
OpenAlexW3039038580

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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.