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)

• ClinicalTrials.gov Identifier: NCT02043678
• Recruitment Status: Completed
• First Posted: January 23, 2014
• Results First Posted: March 5, 2019
• Last Update Posted: February 26, 2024
• Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Bayer

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Prostatic Neoplasms	Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Drug: Matching placebo (normal saline); Drug: Abiraterone; Drug: Prednisone/Prednisolone	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 806 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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)
• Actual Study Start Date: March 30, 2014
• Actual Primary Completion Date: February 15, 2018
• Actual Study Completion Date: February 8, 2024

Arms and Interventions

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: Matching placebo (normal saline); 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

Outcome Measures

Primary Outcome Measures :

1. Symptomatic Skeletal Event Free Survival (SSE-FS) [ Time Frame: From randomization until first onset of on-study symptomatic skeletal event (SSE) or death, up to 47 months ]
   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.

Secondary Outcome Measures :

1. Overall Survival (OS) [ Time Frame: From randomization until death from any cause, up to 67 months ]
   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.
2. Radiological Progression Free Survival (rPFS) [ Time Frame: From randomization until the date of confirmed radiological progression or death, up to 47 months ]
   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.
3. Time to Pain Progression [ Time Frame: From randomization until the date of pain progression based on pain score, up to 47 months ]
   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.
4. Time to Cytotoxic Chemotherapy [ Time Frame: From randomization until the date of first cytotoxic chemotherapy, up to 47 months ]
   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.
5. Time to Opiate Use for Cancer Pain [ Time Frame: From randomization until the date of opiate use, up to 47 months ]
   Time to opiate use for cancer pain was defined as the interval from the date of randomization to the date of opiate use.
6. Number of Participants With Treatment-emergent Adverse Events [ Time Frame: From start of study treatment until the end of the treatment period, up to 65 months ]
   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.
7. Number of Subjects With Radium-223/Placebo-related Treatment-emergent Adverse Events Per Maximum Intensity [ Time Frame: From start of study treatment until the end of the treatment period, up to 65 months ]
   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.
8. Number of Participants With Any Treatment-emergent Additional Primary Malignancies [ Time Frame: From start of study treatment until 4 weeks after last study treatment, up to 65 months ]
   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.
9. Number of Participants With Treatment-emergent Bone Fractures [ Time Frame: From start of study treatment until 4 weeks after last study treatment, up to 65 months ]
   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.
10. Number of Participants With Post-treatment Adverse Events [ Time Frame: After the treatment period, up to 46 months ]
    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.
11. Number of Participants With Any Study Drug-related Post-treatment Adverse Events Per Maximum Intensity [ Time Frame: After the treatment period, up to 46 months ]
    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.
12. Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders [ Time Frame: After the treatment period, up to 46 months ]
    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.
13. Number of Participants With Post-treatment Bone Fractures [ Time Frame: After the treatment period, up to 46 months ]
    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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Alaska

Anchorage, Alaska, United States, 99503

United States, Arizona

Tucson, Arizona, United States, 85704

Tucson, Arizona, United States, 85718

United States, California

Oceanside, California, United States, 92056

United States, Colorado

Denver, Colorado, United States, 80211

United States, District of Columbia

Washington, District of Columbia, United States, 20007-2113

United States, Florida

Fort Myers, Florida, United States, 33901

United States, Georgia

Atlanta, Georgia, United States, 30322

United States, Indiana

Jeffersonville, Indiana, United States, 47130

United States, Louisiana

New Orleans, Louisiana, United States, 70112

United States, Maryland

Baltimore, Maryland, United States, 21201

Rockville, Maryland, United States, 20850

Towson, Maryland, United States, 21204

United States, Massachusetts

Boston, Massachusetts, United States, 02114-2696

Burlington, Massachusetts, United States, 01805

United States, Michigan

Detroit, Michigan, United States, 48202

Traverse City, Michigan, United States, 49684

United States, Missouri

Saint Louis, Missouri, United States, 63110

United States, Nebraska

Omaha, Nebraska, United States, 68130

United States, Nevada

Las Vegas, Nevada, United States, 89169

United States, New Jersey

Hackensack, New Jersey, United States, 07601

United States, New York

Poughkeepsie, New York, United States, 12601

Syracuse, New York, United States, 13210

United States, Pennsylvania

Bala-Cynwyd, Pennsylvania, United States, 19004

Pittsburgh, Pennsylvania, United States, 15215

Pittsburgh, Pennsylvania, United States, 15240

United States, Virginia

Norfolk, Virginia, United States, 23502

United States, Washington

Seattle, Washington, United States, 98109-1023

Spokane, Washington, United States, 99208-1129

United States, West Virginia

Wheeling, West Virginia, United States, 26003

Australia, New South Wales

St Leonards, New South Wales, Australia, 2065

Australia, South Australia

Adelaide, South Australia, Australia, 5000

Australia, Victoria

East Bentleigh, Victoria, Australia, 3165

Fitzroy, Victoria, Australia, 3065

Heidelberg, Victoria, Australia, 3084

Australia

Darlinghurst, Australia, 2010

East Melbourne, Australia, 3002

Randwick, Australia, 2031

Belgium

Bruxelles - Brussel, Belgium, 1200

Bruxelles, Belgium, 1070

Edegem, Belgium, 2650

Gent, Belgium, 9000

Brazil

Belo Horizonte, Minas Gerais, Brazil, 30130-090

Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090

Barretos/SP, Sao Paulo, Brazil, 14784-400

São Paulo, Sao Paulo, Brazil, 01246-000

Sao Paulo, Brazil, 01409-000

Canada, Alberta

Calgary, Alberta, Canada, T2N 4N2

Canada, British Columbia

Vancouver, British Columbia, Canada, V5Z 4E6

Canada, Manitoba

Winnipeg, Manitoba, Canada, R3A 1R9

Canada, Ontario

Hamilton, Ontario, Canada, L8V 5C2

Ottawa, Ontario, Canada, K1H 8L6

Toronto, Ontario, Canada, M4N 3M5

Canada, 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

Paris, France, 75005

Paris, France, 75010

POITIERS cedex, France, 86021

Saint-Herblain, France, 44800

Toulouse Cedex 9, France, 31059

Germany

Ulm, Baden-Württemberg, Germany, 89075

München, Bayern, Germany, 81675

Marburg, Hessen, Germany, 35043

Münster, Nordrhein-Westfalen, Germany, 48149

Dresden, Sachsen, Germany, 01307

Jena, Thüringen, Germany, 07747

Berlin, Germany, 12203

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

Modena, Emilia-Romagna, Italy, 41124

Roma, Lazio, Italy, 00152

Roma, Lazio, Italy, 00189

Genova, Liguria, Italy, 16128

Milano, Lombardia, Italy, 20133

Milano, Lombardia, Italy, 20141

Cagliari, Sardegna, Italy, 09125

Arezzo, Toscana, Italy, 52100

Trento, Trentino-Alto Adige, Italy, 38100

Japan

Nagoya, Aichi, Japan, 466-8560

Hirosaki, Aomori, Japan, 036-8563

Kashiwa, Chiba, Japan, 277-8577

Matsuyama, Ehime, Japan, 791-0280

Sapporo, Hokkaido, Japan, 003-0804

Kobe, Hyogo, Japan, 650-0047

Tsukuba, Ibaraki, Japan, 305-8576

Kanazawa, Ishikawa, Japan, 920-8641

Kita, Kagawa, Japan, 761-0793

Yokohama, Kanagawa, Japan, 236-0004

Yokohama, Kanagawa, Japan, 241-8515

Sendai, Miyagi, Japan, 980-8574

Matsumoto, Nagano, Japan, 390-8621

Kurashiki, Okayama, Japan, 701-0192

Osakasayama, Osaka, Japan, 589-8511

Hamamatsu, Shizuoka, Japan, 431-3192

Bunkyo-ku, Tokyo, Japan, 113-8431

Bunkyo-ku, Tokyo, Japan, 113-8603

Koto-ku, Tokyo, Japan, 135-8550

Shinjuku-ku, Tokyo, Japan, 160-8582

Ube, Yamaguchi, Japan, 755-8505

Chiba, Japan, 260-8677

Chiba, Japan, 260-8717

Fukuoka, Japan, 811-1395

Fukuoka, Japan, 812-8582

Kumamoto, Japan, 860-0008

Miyazaki, Japan, 889-1692

Nagasaki, Japan, 852-8501

Okayama, Japan, 700-8558

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, 168583

Singapore, Singapore, 258499

Spain

Oviedo, Asturias, Spain, 33006

Badalona, Barcelona, Spain, 08916

Hospitalet de Llobregat, Barcelona, Spain, 08907

Malaga, Málaga, Spain, 29010

Barcelona, Spain, 08035

Barcelona, Spain, 08036

Madrid, Spain, 28007

Madrid, Spain, 28033

Madrid, Spain, 28034

Madrid, Spain, 28046

Madrid, Spain, 28050

Pamplona, Spain, 31008

Sevilla, Spain, 41071

Sweden

Linköping, Sweden, 58185

Stockholm, Sweden, 171 76

Sundsvall, Sweden, 851 86

Umea, Sweden, 901 85

Växjö, Sweden, 351 85

United Kingdom

Edinburgh, Lothian, United Kingdom, EH4 2XU

Bebington, Merseyside, United Kingdom, CH63 4JY

Northwood, Middlesex, United Kingdom, HA6 2VR

Guildford, Surrey, United Kingdom, GU2 7XX

Sutton, Surrey, United Kingdom, SM2 5PT

Newcastle Upon Tyne, Tyne And Wear, United Kingdom, NE4 6BE

Coventry, West Midlands, United Kingdom, CV22DX

Belfast, United Kingdom, BT9 7AB

Leeds, United Kingdom, LS9 7TF

London, United Kingdom, NW3 2QG

Romford, United Kingdom, RM7 0AG

Sponsors and Collaborators

Bayer

Janssen Research & Development, LLC

Investigators

• Study Director: Bayer Study Director; Bayer

  Study Documents (Full-Text)

Documents provided by Bayer:

Study Protocol  [PDF] April 3, 2018

Statistical Analysis Plan  [PDF] July 10, 2017

More Information

Additional Information:

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. 

Click here to find information about studies related to Bayer Healthcare products conducted in Europe 

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02043678
• Other Study ID Numbers: 15396; 2013-003438-33 ( EudraCT Number )
• First Posted: January 23, 2014
• Results First Posted: March 5, 2019
• Last Update Posted: February 26, 2024
• Last Verified: February 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:

Phase III; Radium-223 dichloride; Abiraterone acetate; Combination therapy; Chemotherapy-naive; Bone metastasis; Castration-resistant prostate cancer (CRPC)

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Prednisone; Prednisolone; Radium Ra 223 dichloride; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents