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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)

Primary Purpose

Prostatic Neoplasms

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Radium-223 dichloride (Xofigo, BAY88-8223)
Matching placebo (normal saline)
Abiraterone
Prednisone/Prednisolone
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Phase III, Radium-223 dichloride, Abiraterone acetate, Combination therapy, Chemotherapy-naive, Bone metastasis, Castration-resistant prostate cancer (CRPC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Radium-223 dichloride + Abi/Pred

Placebo + Abi/Pred

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 21, 2014
Last Updated
October 12, 2023
Sponsor
Bayer
Collaborators
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02043678
Brief Title
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
Acronym
ERA 223
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 30, 2014 (Actual)
Primary Completion Date
February 15, 2018 (Actual)
Study Completion Date
March 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Phase III, Radium-223 dichloride, Abiraterone acetate, Combination therapy, Chemotherapy-naive, Bone metastasis, Castration-resistant prostate cancer (CRPC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
806 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radium-223 dichloride + Abi/Pred
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo + Abi/Pred
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Radium-223 dichloride (Xofigo, BAY88-8223)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Matching placebo (normal saline)
Intervention Description
Intravenous injection ( IV-slow bolus), every 4 weeks for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Abiraterone
Intervention Description
1000 mg once daily, oral, with best supportive care
Intervention Type
Drug
Intervention Name(s)
Prednisone/Prednisolone
Intervention Description
5 mg twice daily, oral, with best supportive care
Primary Outcome Measure Information:
Title
Symptomatic Skeletal Event Free Survival (SSE-FS)
Description
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.
Time Frame
From randomization until first onset of on-study symptomatic skeletal event (SSE) or death, up to 47 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
From randomization until death from any cause, up to 67 months
Title
Radiological Progression Free Survival (rPFS)
Description
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.
Time Frame
From randomization until the date of confirmed radiological progression or death, up to 47 months
Title
Time to Pain Progression
Description
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.
Time Frame
From randomization until the date of pain progression based on pain score, up to 47 months
Title
Time to Cytotoxic Chemotherapy
Description
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.
Time Frame
From randomization until the date of first cytotoxic chemotherapy, up to 47 months
Title
Time to Opiate Use for Cancer Pain
Description
Time to opiate use for cancer pain was defined as the interval from the date of randomization to the date of opiate use.
Time Frame
From randomization until the date of opiate use, up to 47 months
Title
Number of Participants With Treatment-emergent Adverse Events
Description
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.
Time Frame
From start of study treatment until the end of the treatment period, up to 65 months
Title
Number of Subjects With Radium-223/Placebo-related Treatment-emergent Adverse Events Per Maximum Intensity
Description
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.
Time Frame
From start of study treatment until the end of the treatment period, up to 65 months
Title
Number of Participants With Any Treatment-emergent Additional Primary Malignancies
Description
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.
Time Frame
From start of study treatment until 4 weeks after last study treatment, up to 65 months
Title
Number of Participants With Treatment-emergent Bone Fractures
Description
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.
Time Frame
From start of study treatment until 4 weeks after last study treatment, up to 65 months
Title
Number of Participants With Post-treatment Adverse Events
Description
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.
Time Frame
After the treatment period, up to 46 months
Title
Number of Participants With Any Study Drug-related Post-treatment Adverse Events Per Maximum Intensity
Description
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.
Time Frame
After the treatment period, up to 46 months
Title
Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders
Description
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.
Time Frame
After the treatment period, up to 46 months
Title
Number of Participants With Post-treatment Bone Fractures
Description
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.
Time Frame
After the treatment period, up to 46 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99503
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007-2113
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2696
Country
United States
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208-1129
Country
United States
City
Wheeling
State/Province
West Virginia
ZIP/Postal Code
26003
Country
United States
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
City
East Bentleigh
State/Province
Victoria
ZIP/Postal Code
3165
Country
Australia
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
City
Darlinghurst
ZIP/Postal Code
2010
Country
Australia
City
East Melbourne
ZIP/Postal Code
3002
Country
Australia
City
Randwick
ZIP/Postal Code
2031
Country
Australia
City
Bruxelles - Brussel
ZIP/Postal Code
1200
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30110-090
Country
Brazil
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
City
Barretos/SP
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
01308-050
Country
Brazil
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
City
Seinäjoki
ZIP/Postal Code
60220
Country
Finland
City
Tampere
ZIP/Postal Code
33521
Country
Finland
City
Besancon
ZIP/Postal Code
25030
Country
France
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
City
Paris
ZIP/Postal Code
75005
Country
France
City
Paris
ZIP/Postal Code
75010
Country
France
City
POITIERS cedex
ZIP/Postal Code
86021
Country
France
City
Saint-Herblain
ZIP/Postal Code
44800
Country
France
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89075
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35043
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07747
Country
Germany
City
Berlin
ZIP/Postal Code
12203
Country
Germany
City
Afula
ZIP/Postal Code
1834111
Country
Israel
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
City
Ramat Gan
ZIP/Postal Code
5262000
Country
Israel
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
City
Zrifin
ZIP/Postal Code
7030000
Country
Israel
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41124
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
City
Genova
State/Province
Liguria
ZIP/Postal Code
16128
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09125
Country
Italy
City
Arezzo
State/Province
Toscana
ZIP/Postal Code
52100
Country
Italy
City
Trento
State/Province
Trentino-Alto Adige
ZIP/Postal Code
38100
Country
Italy
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8563
Country
Japan
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
City
Kita
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
City
Matsumoto
State/Province
Nagano
ZIP/Postal Code
390-8621
Country
Japan
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
701-0192
Country
Japan
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
City
Ube
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
City
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
City
Kumamoto
ZIP/Postal Code
860-0008
Country
Japan
City
Miyazaki
ZIP/Postal Code
889-1692
Country
Japan
City
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
City
Bodø
ZIP/Postal Code
8092
Country
Norway
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
City
Oslo
ZIP/Postal Code
0450
Country
Norway
City
Gdansk
ZIP/Postal Code
80-214
Country
Poland
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
City
Poznan
ZIP/Postal Code
61-485
Country
Poland
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
City
Singapore
ZIP/Postal Code
168583
Country
Singapore
City
Singapore
ZIP/Postal Code
258499
Country
Singapore
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Malaga
State/Province
Málaga
ZIP/Postal Code
29010
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28033
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Madrid
ZIP/Postal Code
28050
Country
Spain
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
City
LInköping
ZIP/Postal Code
58185
Country
Sweden
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
City
Sundsvall
ZIP/Postal Code
851 86
Country
Sweden
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden
City
Växjö
ZIP/Postal Code
351 85
Country
Sweden
City
Edinburgh
State/Province
Lothian
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
City
Bebington
State/Province
Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2VR
Country
United Kingdom
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
City
Coventry
State/Province
West Midlands
ZIP/Postal Code
CV22DX
Country
United Kingdom
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
City
Romford
ZIP/Postal Code
RM7 0AG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
30738780
Citation
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.
Results Reference
result
PubMed Identifier
32404868
Citation
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.
Results Reference
derived
PubMed Identifier
31823152
Citation
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.
Results Reference
derived
Links:
URL
https://clinicaltrials.bayer.com/
Description
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.
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

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

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