Evidence map›Paper›PMID 38305451›Full record

Observational studyJapanese journal of clinical oncology2024

Determination of enzalutamide long-term safety and efficacy for castration-resistant prostate cancer patients after combined anti-androgen blockade followed by alternative anti-androgen therapy: a multicenter prospective DELC study.

Akira Nagahara, Motohide Uemura, Mototaka Sato, Wataru Nakata, Masao Tsujihata, Tetsuya Takao, Soichi Matsumura, Kensaku Nishimura, Shingo Takada, Toshichika Iwanishi and 11 more

Open access · hybridAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Japanese journal of clinical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 40% 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

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Myosteatosis Predicts Poor Prognosis in Patients With Castration-Resistant Prostate Cancer Treated With Enzalutamide.International journal of urology : official journal of the Japanese Urological Association · 2026
    Article
  2. 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

21 authors at 15 institutions in 1 country.

Akira NagaharaDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
Motohide UemuraDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.ORCID 0000-0001-7263-7965
Mototaka SatoDepartment of Urology, Toyonaka Municipal Hospital, Toyonaka, Osaka, Japan.
Wataru NakataDepartment of Urology, Osaka Rosai Hospital, Sakai, Osaka, Japan.
Masao TsujihataDepartment of Urology, Osaka Rosai Hospital, Sakai, Osaka, Japan.
Tetsuya TakaoDepartment of Urology, Osaka General Medical Center, Osaka, Japan.
Soichi MatsumuraDepartment of Urology, Hyogo Prefectural Nishinomiya Hospital, Nishinomiya, Hyogo, Japan.
Kensaku NishimuraDepartment of Urology, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Shingo TakadaDepartment of Urology, Osaka Police Hospital, Osaka, Japan.
Toshichika IwanishiDepartment of Urology, Sakai City Medical Center, Sakai, Osaka, Japan.
Yasuyuki KobayashiDepartment of Urology, Kinki Central Hospital of Mutual Aid Association of Public School Teachers, Itami, Hyogo, Japan.
Yu IshizuyaDepartment of Urology, Higashiosaka City Medical Center, Higashiosaka, Osaka, Japan.
Tsuyoshi TakadaDepartment of Urology, Minoh City Hospital, Minoh, Osaka, Japan.
Koichi OkadaDepartment of Urology, Sumitomo Hospital, Osaka, Japan.
Hitoshi InoueDepartment of Urology, Ikeda City Hospital, Ikeda, Osaka, Japan.
Taigo KatoDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
Koji HatanoDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
Atsunari KawashimaDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
Takeshi UjikeDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
Kazutoshi FujitaDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
Norio NonomuraDepartment of Urology, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
The University of Osaka · JPOsaka Rosai Hospital · JPFukushima Medical University · JPHyogo Prefectural Nishinomiya Hospital · JPIkeda Municipal Hospital · JPKindai University · JPKinki Central Hospital · JPMinoh City Hospital · JPOsaka International Cancer Institute · JPOsaka National Hospital · JPOsaka Police Hospital · JPOsaka Prefectural Medical Center · JPSakai Municipal Hospital · JPSumitomo Hospital · JPToyonaka Municipal Hospital · JP

Funding

Astellas Pharma Inc.
6 · The paper itself

Abstract

backgroundAlternative anti-androgen therapy has been widely used as a first-line treatment for castration-resistant prostate cancer, and it may affect treatment outcome of subsequent agents targeting the androgen receptor axis. We conducted the prospective observational DELC (Determination of Enzalutamide Long-term safety and efficacy for Castration-resistant prostate cancer patients after combined anti-androgen blockade followed by alternative anti-androgen therapy) study to evaluate the efficacy of enzalutamide in patients with castration-resistant prostate cancer who underwent prior combined androgen blockade with bicalutamide and then alternative anti-androgen therapy with flutamide.

methodsThe DELC study enrolled 163 Japanese patients with castration-resistant prostate cancer who underwent alternative anti-androgen therapy with flutamide following failure of initial combined androgen blockade with bicalutamide in multiple institutions between January 2016 and March 2019. Primary endpoint was overall survival. Administration of enzalutamide was started at 160 mg orally once daily in all patients.

resultsThe rate of decline of prostate-specific antigen by 50% or more was 72.2%, and median overall survival was 42.05 months. Multivariate analysis revealed that higher pretreatment serum levels of prostate-specific antigen (≥11.3 ng/mL; P = 0.004), neuron-specific enolase (P = 0.014) and interleukin-6 (≥2.15 pg/mL; P = 0.004) were independent risk factors for overall survival. Fatigue (30.0%), constipation (19.6%) and appetite loss (17.8%) were the most common clinically relevant adverse events. The enzalutamide dose was not reduced in any patient under the age of 70, but adherence was decreased in those over 70.

conclusionsIn the DELC study, the safety of enzalutamide was comparable to that in previous reports. Serum levels of neuron-specific enolase and interleukin-6 were suggested as prognostic factors for castration-resistant prostate cancer with potential clinical utility.

Indexed as

Androgen AntagonistsBenzamidesNitrilesPhenylthiohydantoinProstatic Neoplasms, Castration-ResistantAgedAged, 80 and overAnilidesAntineoplastic Combined Chemotherapy ProtocolsFlutamideHumansMaleMiddle AgedProspective StudiesProstate-Specific AntigenTosyl CompoundsAndrogen AntagonistsAnilidesBenzamidesbicalutamideenzalutamideFlutamideNitrilesPhenylthiohydantoinProstate-Specific AntigenTosyl Compoundsbicalutamidecastration-resistant prostate cancerenzalutamideflutamide

Identifiers

PMID38305451
PMCPMC11075733
OpenAlexW4391463482

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.