Evidence map›Paper›PMID 31823152›Full record

Trial reportInternational journal of clinical oncology2020

A randomized, double-blind, comparison of radium-223 and placebo, in combination with abiraterone acetate and prednisolone, in castration-resistant metastatic prostate cancer: subgroup analysis of Japanese patients in the ERA 223 study.

Nobuaki Matsubara, Go Kimura, Hiroji Uemura, Hirotsugu Uemura, Motonobu Nakamura, Satoshi Nagamori, Atsushi Mizokami, Hiroaki Kikukawa, Makoto Hosono, Seigo Kinuya and 3 more

Registry-linked trialAbstract readRandomized 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 NCT02043678 (A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 22% 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.

NCT02043678 phase3completednot on this map

A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer(CRPC)

TypeinterventionalSponsorBayerRan2014 to 2024Enrolled806ConditionsProstatic NeoplasmsArmsRadium-223 dichloride (Xofigo, BAY88-8223), Matching placebo (normal saline), Abiraterone, Prednisone/Prednisolone
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Administration of radium-223 and the prognosis in Japanese bone metastatic castration-resistant prostate cancer patients: A large database study.International journal of urology : official journal of the Japanese Urological Association · 2022
    Article
  5. Review
  6. 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

13 authors at 11 institutions in 3 countries.

Nobuaki MatsubaraDivision of Breast and Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. nmatsuba@east.ncc.go.jp.
Go KimuraDepartment of Urology, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan.
Hiroji UemuraDepartment of Urology and Renal Transplantation, Yokohama City University Medical Center, 4-57, Urafune-cho, Minami-ku, Yokohama, Japan.
Hirotsugu UemuraDepartment of Urology, Kindai University Faculty of Medicine, 377-2, Ohno-Higashi, Osaka-Sayama, Osaka, Japan.
Motonobu NakamuraDepartment of Urology, National Hospital Organization Kyushu Cancer Center, Fukuoka, 811-1395, Japan.
Satoshi NagamoriDepartment of Urology, National Hospital Organization Hokkaido Cancer Center, 2-3-54 Kikusui 4 Jo, Shiroishi-ku, Sapporo, Japan.
Atsushi MizokamiDepartment of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, 13-1 Takaramachi, Kanazawa, Ishikawa, Japan.
Hiroaki KikukawaDepartment of Urology, National Hospital Organization Kumamoto Medical Center, 1-5 Ninomaru, Chuo-ku, Kumamoto, Japan.
Makoto HosonoThe Japanese Society of Nuclear Medicine, 2-28-45, Honkomagome, Bunkyo-ku, Tokyo, Japan.
Seigo KinuyaThe Japanese Society of Nuclear Medicine, 2-28-45, Honkomagome, Bunkyo-ku, Tokyo, Japan.
Heiko KrisselClinical Development, SBU Oncology, Bayer AG, Berlin, Germany.
Jonathan SiegelClinical Statistics, Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.
Yoshiyuki KakehiKagawa University, Takamatsu, Kagawa, Japan.
Japanese Society of Medical Oncology · JPYokohama City University · JPBayer (Germany) · DEBayer (United States) · USKagawa University · JPKanazawa University · JPKumamoto Medical Center · JPNational Cancer Center Hospital East · JPNational Hospital Organization Hokkaido Medical Center · JPNational Hospital Organization Kyushu Cancer Center · JPNippon Medical School · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundERA 223 compared concurrent abiraterone acetate/prednisolone (AAP) plus radium-223 with AAP plus placebo in men with chemotherapy-naïve asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. We report data from a subgroup of Japanese patients in ERA 223.

methodsPatients were randomized to radium-223 (55 kBq/kg) or placebo once every 4 weeks (max. 6 cycles), and also received oral abiraterone acetate 1000 mg once daily plus prednisone/prednisolone 5 mg twice daily during and after radium-223/placebo treatment, until a symptomatic skeletal event (SSE). The primary endpoint was SSE-free survival (SSE-FS); overall survival (OS) was a secondary endpoint.

resultsOf 806 patients randomized in ERA 223, 114 patients (57 per arm) were enrolled in Japan. SSE-FS was not improved significantly in the radium-223 arm [25.5 months, 95% CI 20.6-not estimated (NE)] compared with the placebo arm (28.7 months, 95% CI 19.7-NE) (HR = 0.907, 95% CI 0.501-1.642). OS and other secondary endpoints were not improved significantly in the radium-223 arm. The incidence of fracture was 23% and 11% in the radium-223 and placebo arms, respectively. The incidence of death was 32% and 36%, respectively.

conclusionsIn the Japanese ERA 223 subgroup, concurrent treatment with AAP and radium-223 did not significantly improve SSE-FS and increased the incidence of fracture, similar to outcomes achieved in the overall population, while an increased incidence of death was not evident. The combination of radium-223 with AAP is not recommended in Japanese patients with asymptomatic or mildly symptomatic mCRPC and bone metastases. CLINICAL

trial registrationClinical trial registration no: NCT02043678.

Indexed as

Abiraterone AcetateAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsAsian PeopleBone NeoplasmsDisease-Free SurvivalDouble-Blind MethodFractures, BoneHumansMaleMiddle AgedPlacebosPrednisolonePrednisoneProstatic Neoplasms, Castration-ResistantAbiraterone AcetatePlacebosPrednisolonePrednisoneRadiumRadium-223Abiraterone acetateCastration-resistant prostate cancerFracturesJapanese patientsRadium-223Symptomatic skeletal event

Identifiers

PMID31823152
OpenAlexW2994960678

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.