Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms (ERA 223)

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)

To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Drug: Abiraterone; Drug: Prednisone/Prednisolone; Drug: Matching placebo (normal saline)

Detailed Description

This study is a phase III multinational, multicenter,randomized, double blind, placebo controlled, study with a randomization allocation ratio of 1:1 (radium-223 dichloride plus abiraterone acetate plus prednisone/prednisolone: placebo plus abiraterone acetate plus prednisone/prednisolone). Until the final overall survival (OS) analysis, the study period consisted of screening / randomization, treatment, active follow-up with clinic visits, active follow-up without clinic visits, and longterm follow-up phases. Up until this point, subjects received study treatment (radium-223 dichloride or placebo in addition to abiraterone acetate plus prednisone / prednisolone for the first 6 cycles followed by abiraterone acetate plus prednisone / prednisolone thereafter) until an on-study SSE occurred (or other withdrawal criteria were met). After the final OS analysis (after implementation of Amendment 7), in order to reduce the burden to study subjects, evaluation of efficacy and exploratory endpoints will be discontinued, except for symptomatic skeletal event (SSE) and OS. Subjects who are discontinued from study treatment will initiate the long-term follow-up period; therefore, active follow-up periods will no longer be applicable. Subjects who are in active follow-up at the time of Amendment 7 is implemented should have the end of active follow-up completed (protocol driven decision) and should be directly transitioned into the extended safety follow-up study. Long term follow-up will continue until the subject dies, is lost to follow-up, withdraws informed consent, actively objects to collection of further data , or is transitioned to the extended safety follow-up study. Subjects will be followed for safety for up to 7 years, which eventually will be completed in this study or in the extended safety follow-up study.

• Study Type: Interventional
• Enrollment (Actual): 806
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Darlinghurst, Australia, 2010
  • East Melbourne, Australia, 3002
  • Randwick, Australia, 2031
  • New South Wales
    • St Leonards, New South Wales, Australia, 2065
  • South Australia
    • Adelaide, South Australia, Australia, 5000
  • Victoria
    • East Bentleigh, Victoria, Australia, 3165
    • Fitzroy, Victoria, Australia, 3065
    • Heidelberg, Victoria, Australia, 3084
• Belgium
  • Bruxelles, Belgium, 1070
  • Bruxelles - Brussel, Belgium, 1200
  • Edegem, Belgium, 2650
  • Gent, Belgium, 9000
• Brazil
  • Sao Paulo, Brazil, 01409-000
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-090
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
  • Sao Paulo
    • Barretos/SP, Sao Paulo, Brazil, 14784-400
    • São Paulo, Sao Paulo, Brazil, 01246-000
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
    • Ottawa, Ontario, Canada, K1H 8L6
    • Toronto, Ontario, Canada, M4N 3M5
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
    • Québec, Quebec, Canada, G1R 2J6
• Finland
  • Helsinki, Finland, 00290
  • Kuopio, Finland, 70210
  • Seinäjoki, Finland, 60220
  • Tampere, Finland, 33521
• France
  • Besancon, France, 25030
  • Bordeaux Cedex, France, 33076
  • POITIERS cedex, France, 86021
  • Paris, France, 75010
  • Paris, France, 75005
  • Saint-Herblain, France, 44800
  • Toulouse Cedex 9, France, 31059
• Germany
  • Berlin, Germany, 12203
  • Baden-Württemberg
    • Ulm, Baden-Württemberg, Germany, 89075
  • Bayern
    • München, Bayern, Germany, 81675
  • Hessen
    • Marburg, Hessen, Germany, 35043
  • Nordrhein-Westfalen
    • Münster, Nordrhein-Westfalen, Germany, 48149
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
  • Thüringen
    • Jena, Thüringen, Germany, 07747
• Israel
  • Afula, Israel, 1834111
  • Beer Sheva, Israel, 8410101
  • Haifa, Israel, 3109601
  • Jerusalem, Israel, 9112001
  • Kfar Saba, Israel, 4428164
  • Petach Tikva, Israel, 4941492
  • Ramat Gan, Israel, 5262000
  • Tel Aviv, Israel, 6423906
  • Zrifin, Israel, 7030000
• Italy
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 41124
  • Lazio
    • Roma, Lazio, Italy, 00152
    • Roma, Lazio, Italy, 00189
  • Liguria
    • Genova, Liguria, Italy, 16128
  • Lombardia
    • Milano, Lombardia, Italy, 20133
    • Milano, Lombardia, Italy, 20141
  • Sardegna
    • Cagliari, Sardegna, Italy, 09125
  • Toscana
    • Arezzo, Toscana, Italy, 52100
  • Trentino-Alto Adige
    • Trento, Trentino-Alto Adige, Italy, 38100
• Japan
  • Chiba, Japan, 260-8677
  • Chiba, Japan, 260-8717
  • Fukuoka, Japan, 812-8582
  • Fukuoka, Japan, 811-1395
  • Kumamoto, Japan, 860-0008
  • Miyazaki, Japan, 889-1692
  • Nagasaki, Japan, 852-8501
  • Okayama, Japan, 700-8558
  • Aichi
    • Nagoya, Aichi, Japan, 466-8560
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8563
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0804
  • Hyogo
    • Kobe, Hyogo, Japan, 650-0047
  • Ibaraki
    • Tsukuba, Ibaraki, Japan, 305-8576
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-8641
  • Kagawa
    • Kita, Kagawa, Japan, 761-0793
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-8515
    • Yokohama, Kanagawa, Japan, 236-0004
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
  • Okayama
    • Kurashiki, Okayama, Japan, 701-0192
  • Osaka
    • Osakasayama, Osaka, Japan, 589-8511
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8603
    • Bunkyo-ku, Tokyo, Japan, 113-8431
    • Koto-ku, Tokyo, Japan, 135-8550
    • Shinjuku-ku, Tokyo, Japan, 160-8582
  • Yamaguchi
    • Ube, Yamaguchi, Japan, 755-8505
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
  • Nijmegen, Netherlands, 6525 GA
  • Zwolle, Netherlands, 8025 AB
• Norway
  • Bodø, Norway, 8092
  • Lørenskog, Norway, 1478
  • Oslo, Norway, 0450
• Poland
  • Gdansk, Poland, 80-214
  • Gdynia, Poland, 81-519
  • Gliwice, Poland, 44-101
  • Poznan, Poland, 61-485
• Russian Federation
  • Moscow, Russian Federation, 115478
  • Obninsk, Russian Federation, 249036
• Singapore
  • Singapore, Singapore, 119074
  • Singapore, Singapore, 258499
  • Singapore, Singapore, 168583
• Spain
  • Barcelona, Spain, 08036
  • Barcelona, Spain, 08035
  • Madrid, Spain, 28046
  • Madrid, Spain, 28034
  • Madrid, Spain, 28007
  • Madrid, Spain, 28033
  • Madrid, Spain, 28050
  • Pamplona, Spain, 31008
  • Sevilla, Spain, 41071
  • Asturias
    • Oviedo, Asturias, Spain, 33006
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
  • Málaga
    • Malaga, Málaga, Spain, 29010
• Sweden
  • Linköping, Sweden, 58185
  • Stockholm, Sweden, 171 76
  • Sundsvall, Sweden, 851 86
  • Umea, Sweden, 901 85
  • Växjö, Sweden, 351 85
• United Kingdom
  • Belfast, United Kingdom, BT9 7AB
  • Leeds, United Kingdom, LS9 7TF
  • London, United Kingdom, NW3 2QG
  • Romford, United Kingdom, RM7 0AG
  • Lothian
    • Edinburgh, Lothian, United Kingdom, EH4 2XU
  • Merseyside
    • Bebington, Merseyside, United Kingdom, CH63 4JY
  • Middlesex
    • Northwood, Middlesex, United Kingdom, HA6 2VR
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7XX
    • Sutton, Surrey, United Kingdom, SM2 5PT
  • Tyne And Wear
    • Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE4 6BE
  • West Midlands
    • Coventry, West Midlands, United Kingdom, CV22DX
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99503
  • Arizona
    • Tucson, Arizona, United States, 85704
    • Tucson, Arizona, United States, 85718
  • California
    • Oceanside, California, United States, 92056
  • Colorado
    • Denver, Colorado, United States, 80211
  • District of Columbia
    • Washington, District of Columbia, United States, 20007-2113
  • Florida
    • Fort Myers, Florida, United States, 33901
  • Georgia
    • Atlanta, Georgia, United States, 30322
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
  • Maryland
    • Baltimore, Maryland, United States, 21201
    • Rockville, Maryland, United States, 20850
    • Towson, Maryland, United States, 21204
  • Massachusetts
    • Boston, Massachusetts, United States, 02114-2696
    • Burlington, Massachusetts, United States, 01805
  • Michigan
    • Detroit, Michigan, United States, 48202
    • Traverse City, Michigan, United States, 49684
  • Missouri
    • Saint Louis, Missouri, United States, 63110
  • Nebraska
    • Omaha, Nebraska, United States, 68130
  • Nevada
    • Las Vegas, Nevada, United States, 89169
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
  • New York
    • Poughkeepsie, New York, United States, 12601
    • Syracuse, New York, United States, 13210
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
    • Pittsburgh, Pennsylvania, United States, 15240
    • Pittsburgh, Pennsylvania, United States, 15215
  • Virginia
    • Norfolk, Virginia, United States, 23502
  • Washington
    • Seattle, Washington, United States, 98109-1023
    • Spokane, Washington, United States, 99208-1129
  • West Virginia
    • Wheeling, West Virginia, United States, 26003

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the prostate
• Male subjects of age ≥ 18 years
• Prostate cancer progression documented by prostate specific antigen (PSA) according to the Prostate Cancer Working Group 2 (PCWG2) criteria or radiological progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
• Two or more bone metastases on bone scan within 4 weeks prior to randomization with no lung, liver, other visceral and/or brain metastasis
• Asymptomatic or mildly symptomatic prostate cancer
• Subjects who received combined androgen blockade with an anti-androgen must have shown PSA progression after discontinuing the anti-androgen prior to enrollment
• Maintenance of medical castration or surgical castration with testosterone less than 50 ng/dL (1.7nmol/L)
• Eastern Cooperative Oncology Group performance status (ECOG PS) score 0 or 1

Exclusion Criteria:

• Prior cytotoxic chemotherapy for the treatment of CRPC, including taxanes, mitoxantrone and estramustine
• Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone twice daily
• Pathological finding consistent with small cell carcinoma of the prostate
• History of visceral metastasis, or presence of visceral metastasis detected by screening imaging examinations
• History of or known brain metastasis
• Malignant lymphadenopathy exceeding 3 cm in short-axis diameter
• Blood transfusion or erythropoietin stimulating agents prior 4 weeks of screening and during the whole screening period before randomization
• Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Subjects with history of spinal cord compression should have completely recovered
• Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime during the 4- week period prior to randomization.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radium-223 dichloride + Abi/Pred; Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met)	Drug: Radium-223 dichloride (Xofigo, BAY88-8223); 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of NIST update) body weight, intravenous injection (IV-slow bolus), every 4 weeks for 6 cycles; Drug: Abiraterone; 1000 mg once daily, oral, with best supportive care; Drug: Prednisone/Prednisolone; 5 mg twice daily, oral, with best supportive care
Placebo Comparator: Placebo + Abi/Pred; Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met)	Drug: Abiraterone; 1000 mg once daily, oral, with best supportive care; Drug: Prednisone/Prednisolone; 5 mg twice daily, oral, with best supportive care; Drug: Matching placebo (normal saline); Intravenous injection ( IV-slow bolus), every 4 weeks for 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic Skeletal Event Free Survival (SSE-FS)	SSE-FS was defined as time (months) from randomization to the earliest of onset date of skeletal symptoms treated with external beam radiotherapy (EBRT), onset date of pathological bone fracture, onset date of spinal cord compression, procedure date of tumor-related orthopedic surgery, or death from any cause. Subjects who died without prior SSE and ≥ 13 weeks after the last SSE assessment are censored at the last SSE assessment date. Subjects alive at the survival cut-off date are censored at the last date known to be alive. Subjects with multiple events are only counted for the category in which the first event occurred. If multiple SSE (component events) occur on the same date for 1 subject, the subject is only counted into 1 category in the order of: spinal cord compression > bone fracture > orthopedic surgery > EBRT.	From randomization until first onset of on-study symptomatic skeletal event (SSE) or death, up to 47 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS was defined as the time (months) from the date of randomization to the date of death due to any cause. Subjects alive at the survival cut-off date were censored at the last date known to be alive.	From randomization until death from any cause, up to 67 months
Radiological Progression Free Survival (rPFS)	rPFS was defined as the time (months) from the date of randomization to the date of confirmed radiological progression or death (if death occurred before progression) based on independent assessment.	From randomization until the date of confirmed radiological progression or death, up to 47 months
Time to Pain Progression	Time to pain progression was defined as the interval from randomization to the first date a subject experienced pain progression, assessed by BPI-SF (see Baseline Characteristics) and defined as: an increase of 2 or more points in the average worst pain score (WPS) from baseline observed at 2 consecutive evaluations >= 4 weeks apart or initiation of short- or long-acting opioid use for pain for subjects with WPS 0 at baseline; an increase of 2 or more points in the average WPS from baseline observed at 2 consecutive evaluations ≥ 4 weeks apart and an average WPS of ≥ 4 OR initiation of short- or long-acting opioid use for pain for subjects with WPS 1 to 3 at baseline. Subjects without pain progression at the end of study are censored at the last date known to have not progressed: the last evaluation date for pain scores or last visit when recorded opiate use, whichever is last. Subjects with no on-study assessment or no baseline assessment are censored at the date of randomization.	From randomization until the date of pain progression based on pain score, up to 47 months
Time to Cytotoxic Chemotherapy	Time to cytotoxic chemotherapy is time (months) from randomization to the earliest date of the first cytotoxic chemotherapy. Participants who have not started cytotoxic chemotherapy during the study were censored at the last assessment date.	From randomization until the date of first cytotoxic chemotherapy, up to 47 months
Time to Opiate Use for Cancer Pain	Time to opiate use for cancer pain was defined as the interval from the date of randomization to the date of opiate use.	From randomization until the date of opiate use, up to 47 months
Number of Participants With Treatment-emergent Adverse Events	An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. A serious adverse event (SAE) was any untoward medical occurrence that at any dose was resulting in death, was lifethreatening, requires hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity. AEs or SAEs occurring after start of study treatment until the end of the treatment period were defined as treatment-emergent AEs (TEAEs) or serious TEAEs. Drug-related TEAEs or serious TEAEs were those with "reasonable causal relationship" to the study treatment decided by the investigators.	From start of study treatment until the end of the treatment period, up to 65 months
Number of Subjects With Radium-223/Placebo-related Treatment-emergent Adverse Events Per Maximum Intensity	An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. A serious adverse event (SAE) was any untoward medical occurrence that at any dose was resulting in death, was lifethreatening, requires hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity. AEs or SAEs occurring after start of study treatment until the end of the treatment period were defined as treatment-emergent AEs (TEAEs) or serious TEAEs. Radium-223/placebo-related TEAEs or serious TEAEs were those with "reasonable causal relationship" to radium-223 or placebo decided by the investigators.	From start of study treatment until the end of the treatment period, up to 65 months
Number of Participants With Any Treatment-emergent Additional Primary Malignancies	Treatment-emergent additional primary malignancies were adverse events identified as additional primary malignancies that occurred after start of study treatment until the end of the treatment period.	From start of study treatment until 4 weeks after last study treatment, up to 65 months
Number of Participants With Treatment-emergent Bone Fractures	Treatment-emergent fractures were adverse events identified as fractures that occurred after start of study treatment until the end of the treatment period. All bone fractures and bone-associated events (e.g., osteoporosis) were reported as either AEs, or SAEs if the criteria of SAE were met, regardless of the investigator's causality assessment.	From start of study treatment until 4 weeks after last study treatment, up to 65 months
Number of Participants With Post-treatment Adverse Events	An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. Any bleeding event occurring during the study was not documented as an AE because this event was planned to be captured in the assessment of efficacy. AEs that started after the treatment period were defined as post-treatment AEs. Drug-related AEs were those with "reasonable causal relationship" to the study treatment decided by the investigators.	After the treatment period, up to 46 months
Number of Participants With Any Study Drug-related Post-treatment Adverse Events Per Maximum Intensity	An adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. Any bleeding event occurring during the study was not documented as an AE because this event was planned to be captured in the assessment of efficacy. AEs that started after the treatment period were defined as post-treatment AEs. Drug-related AEs were those with "reasonable causal relationship" to the study treatment decided by the investigators.	After the treatment period, up to 46 months
Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders	Post-treatment blood and lymphatic system disorders were adverse events identified as blood and lymphatic system disorders that occurred after the end of the treatment period until participant died, was lost to follow-up, withdrew informed consent, actively objected to collection of further data, or was transitioned to the extended safety follow-up study.	After the treatment period, up to 46 months
Number of Participants With Post-treatment Bone Fractures	Post-treatment fractures were adverse events identified as fractures that occured after the end of the treatment period until participant died, was lost to follow-up, withdrew informed consent, actively objected to collection of further data, or was transitioned to the extended safety follow-up study. All bone fractures and bone-associated events (e.g., osteoporosis), were reported as either AEs, or SAEs if the criteria of SAE were met, regardless of the investigator's causality assessment.	After the treatment period, up to 46 months

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC
• Investigators: Study Director: Bayer Study Director, Bayer

Publications and helpful links

General Publications

• Smith M, Parker C, Saad F, Miller K, Tombal B, Ng QS, Boegemann M, Matveev V, Piulats JM, Zucca LE, Karyakin O, Kimura G, Matsubara N, Nahas WC, Nole F, Rosenbaum E, Heidenreich A, Kakehi Y, Zhang A, Krissel H, Teufel M, Shen J, Wagner V, Higano C. Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):408-419. doi: 10.1016/S1470-2045(18)30860-X. Epub 2019 Feb 6. Erratum In: Lancet Oncol. 2019 Oct;20(10):e559.
• Shore N, Higano CS, George DJ, Sternberg CN, Saad F, Tombal B, Miller K, Kalinovsky J, Jiao X, Tangirala K, Sartor O. Concurrent or layered treatment with radium-223 and enzalutamide or abiraterone/prednisone: real-world clinical outcomes in patients with metastatic castration-resistant prostate cancer. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):680-688. doi: 10.1038/s41391-020-0236-0. Epub 2020 May 13.
• Matsubara N, Kimura G, Uemura H, Uemura H, Nakamura M, Nagamori S, Mizokami A, Kikukawa H, Hosono M, Kinuya S, Krissel H, Siegel J, Kakehi Y. 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. Int J Clin Oncol. 2020 Apr;25(4):720-731. doi: 10.1007/s10147-019-01589-6. Epub 2019 Dec 10.

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe
• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2014
• Primary Completion (Actual): February 15, 2018
• Study Completion (Actual): February 8, 2024

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 21, 2014
• First Posted (Estimated): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Abiraterone acetate; Phase III; Radium-223 dichloride; Castration-resistant prostate cancer (CRPC); Combination therapy; Chemotherapy-naive; Bone metastasis
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisolone; Prednisone; Radium Ra 223 dichloride
• Other Study ID Numbers: 15396; 2013-003438-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No