Evidence map›Paper›PMID 31564004›Full record

Trial reportInternational journal of clinical oncology2020

Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: the OCUU-CRPC study.

Taro Iguchi, Satoshi Tamada, Minoru Kato, Sayaka Yasuda, Yuichi Machida, Tetsuji Ohmachi, Keiichi Ishii, Hiroyuki Iwata, Shinji Yamamoto, Tomohiro Kanamaru and 9 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02346578 (Multicenter, Prospective, Randomised and Comparative Study of AA Therapy and Early Administrating Enzalutamide in Participants With CRPC Previously Treated With CAB Therapy Using Bicalutamide.), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT02346578 phase2completednot on this map

Multicenter, Prospective, Randomised and Comparative Study of AA Therapy and Early Administrating Enzalutamide in Participants With CRPC Previously Treated With CAB Therapy Using Bicalutamide.

TypeinterventionalSponsorTaro Iguchi, MD, PHDRan2014 to 2019Enrolled104ConditionsCastration-resistant Prostate CancerArmsEnzalutamide, Flutamide
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
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  4. Review
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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

19 authors.

Taro IguchiDepartment of Urology, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan. taro@msic.med.osaka-cu.ac.jp.ORCID http://orcid.org/0000-0002-7067-6642
Satoshi TamadaDepartment of Urology, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
Minoru KatoDepartment of Urology, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
Sayaka YasudaDepartment of Urology, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.
Yuichi MachidaDepartment of Urology, Yao Municipal Hospital, Yao, Japan.
Tetsuji OhmachiDepartment of Urology, Bell-land General Hospital, Sakai, Japan.
Keiichi IshiiDepartment of Urology, Osaka City General Hospital, Osaka, Japan.
Hiroyuki IwataDepartment of Urology, Itami City Hospital, Itami, Japan.
Shinji YamamotoDepartment of Urology, Ikuwakai Memorial Hospital, Osaka, Japan.
Tomohiro KanamaruDepartment of Urology, Yao Tokushukai General Hospital, Yao, Japan.
Kazuya MorimotoDepartment of Urology, Osaka General Hospital of West Japan Railway Company, Osaka, Japan.
Taro HaseDepartment of Urology, Suita Municipal Hospital, Suita, Japan.
Koichiro TashiroDepartment of Urology, Meijibashi Hospital, Matsubara, Japan.
Koji HarimotoDepartment of Urology, Fuchu Hospital, Izumi, Japan.
Takashi DeguchiDepartment of Urology, PL Hospital, Tondabayashi, Japan.
Takahisa AdachiDepartment of Urology, Osaka City Juso Hospital, Osaka, Japan.
Katsuki IwamotoDepartment of Urology, Ishikiriseiki Hospital, Higashiosaka, Japan.
Yoshinori TakegakiDepartment of Urology, Minamiosaka Hospital, Osaka, Japan.
Tatsuya NakataniDepartment of Urology, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-machi, Abeno-ku, Osaka, 545-8585, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBefore the androgen target therapy era, flutamide was widely used for castration-resistant prostate cancer in Japan. Enzalutamide is currently the recommended treatment; however, the efficacy and safety of enzalutamide and flutamide after combined androgen blockade therapy with bicalutamide, has not been compared.

methodsPatients with castration-resistant prostate cancer who received combined androgen blockade therapy with bicalutamide were randomly assigned to receive either enzalutamide or flutamide. The primary endpoint for efficacy was the 3-month prostate-specific antigen response rate. This trial is registered with ClinicalTrials.gov (NCT02346578) and the University hospital Medical Information Network (UMIN000016301).

resultsOverall, 103 patients were enrolled. The 3- (80.8% vs. 35.3%; p < 0.001) and 6-month (73.1% vs. 31.4%; p < 0.001) prostate-specific antigen response rates were higher in the enzalutamide than in the flutamide group. The 3-month disease progression rates (radiographic or prostate-specific antigen progression) were 6.4% and 38.8% in the enzalutamide and flutamide groups, respectively [hazard ratio (HR): 0.16; 95% confidence interval (CI): 0.05-0.47; p < 0.001]; the 6-month rates were 11.4% and 51.1%, respectively (HR 0.22; 95% CI 0.09-0.50; p < 0.001). Enzalutamide provided superior prostate-specific antigen progression-free survival compared with flutamide (HR 0.29; 95% CI 0.15-0.54; p < 0.001). Median time to prostate-specific antigen progression-free survival was not reached and was 6.6 months in the enzalutamide and flutamide groups, respectively.

conclusionsAs an alternative anti-androgen therapy in patients with castration-resistant prostate cancer who fail bicalutamide-combined androgen blockade therapy, enzalutamide provides superior clinical outcomes compared with flutamide. Enzalutamide should be preferred over flutamide in these patients.

Indexed as

AgedAged, 80 and overAndrogen AntagonistsAnilidesAntineoplastic Combined Chemotherapy ProtocolsBenzamidesFlutamideHumansKallikreinsMaleMiddle AgedNitrilesPhenylthiohydantoinProgression-Free SurvivalProportional Hazards ModelsProstate-Specific AntigenAndrogen AntagonistsAnilidesBenzamidesbicalutamideenzalutamideFlutamideKallikreinsKLK3 protein, humanNitrilesPhenylthiohydantoinProstate-Specific AntigenTosyl CompoundsCastration-resistant prostate cancerEnzalutamideFlutamideRandomized controlled trial

Identifiers

PMID31564004

What OpenQuestion holds

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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.