Evidence map›Paper›PMID 25425730›Full record

Trial reportJapanese journal of clinical oncology2014

A phase 2 study of abiraterone acetate in Japanese men with metastatic castration-resistant prostate cancer who had received docetaxel-based chemotherapy.

Takefumi Satoh, Hiroji Uemura, Kazunari Tanabe, Tsutomu Nishiyama, Akito Terai, Akira Yokomizo, Tatsuya Nakatani, Keiichiro Imanaka, Seiichiro Ozono, Hideyuki Akaza

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Japanese journal of clinical oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01795703 (A Phase II Study of JNJ-212082), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.7field-weighted citation impact, top 10% 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.

NCT01795703 phase2completednot on this map

A Phase II Study of JNJ-212082 (Abiraterone Acetate) in Metastatic Castration-Resistant Prostate Cancer Patients Who Have Received Docetaxel-based Chemotherapy

TypeinterventionalSponsorJanssen Research & Development, LLCRan2012 to 2014Enrolled47ConditionsProstate CancerArmsAbiraterone, Prednisolone
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 32 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

10 authors at 10 institutions in 2 countries.

Takefumi SatohDepartment of Urology, Kitasato University School of Medicine, Kanagawa tsatoh@kitasato-u.ac.jp.
Hiroji UemuraDepartment of Urology, Yokohama City University Graduate School of Medicine, Kanagawa.
Kazunari TanabeDepartment of Urology, Kidney Center, Tokyo Women's Medical University, Tokyo.
Tsutomu NishiyamaDivision of Urology, Department of Regenerative and Transplant Medicine, Niigata University Graduate School of Medical and Dental Sciences, Niigata.
Akito TeraiDepartment of Urology, Kurashiki Central Hospital, Okayama.
Akira YokomizoDepartment of Urology, Kyushu University Graduate School of Medical Sciences, Fukuoka.
Tatsuya NakataniDepartment of Urology, Osaka City University Graduate School of Medicine, Osaka.
Keiichiro ImanakaJanssen Pharmaceutical K.K., Tokyo.
Seiichiro OzonoDepartment of Urology, Hamamatsu University School of Medicine, Shizuoka.
Hideyuki AkazaResearch Center for Advanced Science and Technology, The University of Tokyo, Tokyo, Japan.
Hamamatsu University School of Medicine · JPJanssen (Belgium) · BEKitasato University · JPKurashiki Central Hospital · JPKyushu University · JPNiigata University · JPOsaka City University · JPThe University of Tokyo · JPTokyo Women's Medical University · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveIn this Phase 2 multicenter study the efficacy and safety of oral abiraterone acetate (1000 mg/once daily) plus prednisolone (5 mg/twice daily) was evaluated in metastatic castration-resistant prostate cancer patients from Japan who had previously received docetaxel-based chemotherapy.

methodsMen (aged ≥20 years) with metastatic castration-resistant prostate cancer (prostate-specific antigen levels: ≥5 ng/ml), who had received 1 or 2 cytotoxic chemotherapies (with ≥1 regimen being docetaxel) for prostate cancer, were enrolled in this open-label, single-arm study. Primary efficacy endpoint was proportion of patients achieving a ≥50% prostate-specific antigen decline from baseline (prostate-specific antigen response rate) after 12-week treatment. Safety and pharmacokinetics were also assessed.

resultsConfirmed prostate-specific antigen response rate by Week 12 was 28.3% (90% confidence interval: 17.6%; 41.1%) or 13 out of 46 (full analysis set) treated patients. However, total prostate-specific antigen response rate including confirmed and unconfirmed responses was 34.8% (90% confidence interval: 23.2%; 47.9%). Secondary efficacy endpoints and outcomes were: improvement in Eastern Cooperative Oncology Group performance status score by ≥1 unit: 7/16 patients (43.8%); objective radiographic response: complete response, partial response and stable disease in 0, 1/22 (4.5%) and 9/22 (40.9%) patients, respectively; pain palliation response: 9/16 (56.3%) patients. The most common adverse events (>20% patients) were upper respiratory tract infection (13/47, 27.7% patients) and hepatic function abnormal (10/47, 21.3% patients, Grade 3: 8.5%). All mineralocorticoid-related toxicities were Grade 1/2.

conclusionsAbiraterone acetate plus prednisolone showed favorable efficacy in metastatic castration-resistant prostate cancer Japanese patients who had received chemotherapy. Abiraterone acetate plus prednisolone had an acceptable safety profile. CLINICAL TRIAL REGISTRATION NO: NCT01795703.

Indexed as

AgedAged, 80 and overAndrostenesAntineoplastic Combined Chemotherapy ProtocolsDocetaxelHumansMaleMiddle AgedNeoplasm MetastasisPrednisoloneProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantTaxoidsabirateroneAndrostenesDocetaxelPrednisoloneProstate-Specific AntigenTaxoidsabiraterone acetatechemotherapyconfirmed response, metastatic castration-resistant prostate cancerprostate-specific antigen

Identifiers

PMID25425730
PMCPMC4243578
OpenAlexW2138922286

What OpenQuestion holds

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LicenceCC BY-NC
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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.