Evidence map›Paper›PMID 39891237›Full record

ArticleBMC research notes2025

Feasibility of enzalutamide on patients with recurrent non-muscle-invasive bladder cancer with marker tumors: phase I study.

Takashi Kawahara, Shuya Kandori, Takahiro Kojima, Bryan J Mathis, Masanobu Shiga, Hiroyuki Nishiyama

Abstract readClinical Trial, Phase I
In one paragraph

Article in BMC research notes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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

6 authors.

Takashi KawaharaDepartment of Urology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan.
Shuya KandoriDepartment of Urology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan. shuya79@md.tsukuba.ac.jp.
Takahiro KojimaDepartment of Urology, Aichi Cancer Center, Nagoya, Japan.
Bryan J MathisInternational Medical Center, University of Tsukuba Affiliated Hospital, Tsukuba, Ibaraki, Japan.
Masanobu ShigaDepartment of Urology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan.
Hiroyuki NishiyamaDepartment of Urology, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveRecent preclinical and retrospective clinical evidence shows that androgen receptor (AR)-mediated signals have significant roles in development of non-muscle invasive bladder cancer (NMIBC). Here, we conducted a single-center, phase I study to assess the feasibility and efficacy of enzalutamide in patients having recurrent NMIBC with marker tumors. Patients with NMIBC who cannot achieve complete transurethral resection (TUR) or with recurrence within a year after the TUR, were enrolled. The patients were administered oral enzalutamide at 160 mg dose, once daily for four weeks. Clinical response at the end of the treatment was evaluated using cystoscopy.

resultsOf the six patients enrolled, two experienced multiple recurrences. All the patients received the planned administration of enzalutamide. Enzalutamide was tolerable and all patients were able to complete the planed treatment, although four patients experienced mild treatment-related adverse events (AEs), but AEs with grade 2 or more were not observed. As for efficacy, three patients showed no change while the remaining three showed disease progression. Immunohistochemical analysis did not showed the strong staining of AR in the latest tumors. This is the first clinical study on enzalutamide treatment for NMIBC patients. In this study, four weeks of enzalutamide administration was well tolerated, however showed no clinical response for non-strong staining of AR.

trial registrationUniversity Hospital Medical Information Network UMIN000026520 (date registration: 2017/3/13).

Indexed as

Antineoplastic AgentsNeoplasm Recurrence, LocalPhenylthiohydantoinUrinary Bladder NeoplasmsAgedBenzamidesBiomarkers, TumorFeasibility StudiesFemaleHumansMaleMiddle AgedNeoplasm InvasivenessNitrilesNon-Muscle Invasive Bladder NeoplasmsReceptors, AndrogenAntineoplastic AgentsBenzamidesBiomarkers, TumorenzalutamideNitrilesPhenylthiohydantoinReceptors, AndrogenAndrogen receptorEnzalutamideNon-muscle invasive bladder cancerPhase 1 study

Identifiers

PMID39891237
PMCPMC11786325

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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.