Evidence map›Paper›PMID 31122212›Full record

Trial reportBMC cancer2019

The LACOG-0415 phase II trial: abiraterone acetate and ADT versus apalutamide versus abiraterone acetate and apalutamide in patients with advanced prostate cancer with non-castration testosterone levels.

Gustavo Werutsky, Fernando Cotait Maluf, Eduardo Henrique Cronemberger, Vinicius Carrera Souza, Suelen Patricia Dos Santos Martins, Fábio Peixoto, Oren Smaletz, Fábio Schutz, Daniel Herchenhorn, Telma Santos and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02867020 (Phase II Randomized Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.1field-weighted citation impact, top 12% 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.

NCT02867020 phase2completednot on this map

Phase II Randomized Study of Abiraterone Acetate Plus ADT Versus APALUTAMIDE Versus Abiraterone and APALUTAMIDE in Patients With Advanced Prostate Cancer With Non-castrate Testosterone Levels

TypeinterventionalSponsorLatin American Cooperative Oncology GroupRan2017 to 2021Enrolled128ConditionsProstate CancerArmsApalutamide, Abiraterone, ADT, Prednisone
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 17 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
  7. Abiraterone Acetate Induces CREB1 Phosphorylation and Enhances the Function of the CBP-p300 Complex, Leading to Resistance in Prostate Cancer Cells.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Article
  8. Article
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 9 institutions in 1 country.

Gustavo WerutskyLatin American Cooperative Oncology Group, Ipiranga Avenue 6681, 99A, Room, Porto Alegre, 806, Brazil. gustavo.werutsky@lacog.org.br.
Fernando Cotait MalufHospital São José, São Paulo, Brazil.
Eduardo Henrique CronembergerCentro Regional Integrado de Oncologia, Fortaleza, Brazil.
Vinicius Carrera SouzaClínica Assistência Multidisciplinar em Oncologia, Salvador, Brazil.
Suelen Patricia Dos Santos MartinsCentro de Estudos e Pesquisa de Hematologia e Oncologia, Santo André, Brazil.
Fábio PeixotoAmericas Centro de Oncologia Integrado, Rio de Janeiro, Brazil.
Oren SmaletzHospital Israelita Albert Einstein, São Paulo, Brazil.
Fábio SchutzBeneficiência Portuguesa de São Paulo, São Paulo, Brazil.
Daniel HerchenhornOncologia D'Or, Rio de Janeiro, Brazil.
Telma SantosJanssen Cilag Pharmaceutical, São Paulo, Brazil.
Flavio Mavignier CarcanoHospital do Câncer de Barretos, Barretos, Brazil.
David Queiroz MunizInstituto do Câncer do Estado de São Paulo, São Paulo, Brazil.
Paulo R S Nunes FilhoLatin American Cooperative Oncology Group, Ipiranga Avenue 6681, 99A, Room, Porto Alegre, 806, Brazil.
Facundo ZaffaroniLatin American Cooperative Oncology Group, Ipiranga Avenue 6681, 99A, Room, Porto Alegre, 806, Brazil.
Carlos BarriosLatin American Cooperative Oncology Group, Ipiranga Avenue 6681, 99A, Room, Porto Alegre, 806, Brazil.
André FayPUCRS School of Medicine, Porto Alegre, Brazil.
Centro de Pesquisas Oncológicas · BRBeneficência Portuguesa de São Paulo · BRD’Or Institute for Research and Education · BRHospital de Câncer de Barretos · BRHospital Israelita Albert Einstein · BRHospital São Paulo · BRInstituto do Câncer do Estado de São Paulo · BRPontifícia Universidade Católica do Rio Grande do Sul · BRSociedade Brasileira de Oncologia Clínica · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTestosterone suppression is the standard treatment for advanced prostate cancer, and it is associated with side-effects that impair patients' quality of life, like sexual dysfunction, osteoporosis, weight gain, and increased cardiovascular risk. We hypothesized that abiraterone acetate with prednisone (AAP) and apalutamide, alone or in combination, can be an effective hormonal therapy also possibly decreasing castration-associated side effects.

methodsPhase II, open-label, randomized, efficacy trial of abiraterone acetate plus prednisone (AAP) and Androgen Deprivation Therapy (ADT) versus apalutamide versus the combination of AAP (without ADT) and apalutamide. Key eligibility criteria are confirmed prostate adenocarcinoma; biochemical relapse after definitive treatment (PSA ≥ 4 ng/ml and doubling time less than 10 months, or PSA ≥ 20 ng/ml); newly diagnosed locally advanced or metastatic prostate cancer; asymptomatic to moderately symptomatic regarding bone symptoms. Patients with other histology besides adenocarcinoma or previous use of hormonal therapy or chemotherapy were excluded. DISCUSSION: There is an urgent need to study and validate regimens such as new hormonal agents that may add benefit to castration with an acceptable safety profile. We aim to evaluate if apalutamide in monotherapy or in combination with AAP is an effective and safety hormonal treatment that can spare patients of androgen deprivation therapy.

trial registrationThis trial was registered in ClinicalTrials.gov on October 16, 2017, under Identifier: NCT02867020.

Indexed as

Abiraterone AcetateAdenocarcinomaAndrogen Receptor AntagonistsAntineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalGoserelinHumansMalePatient Reported Outcome MeasuresPrednisoneProstatic Neoplasms, Castration-ResistantQuality of LifeTestosteroneThiohydantoinsTreatment OutcomeAbiraterone AcetateAndrogen Receptor AntagonistsAntineoplastic Agents, HormonalapalutamideGoserelinPrednisoneTestosteroneThiohydantoinsAbirateroneAndrogen deprivation therapyApalutamideCastration-sensitive prostate cancerGoserelinHormonal therapy

Identifiers

PMID31122212
PMCPMC6533731
OpenAlexW2947586999

What OpenQuestion holds

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LicenceCC BY
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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.