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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02043678
Registration number
NCT02043678
Ethics application status
Date submitted
21/01/2014
Date registered
23/01/2014
Date last updated
26/02/2024
Titles & IDs
Public 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
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Scientific 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)
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Secondary ID [1]
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2013-003438-33
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Secondary ID [2]
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15396
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Universal Trial Number (UTN)
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Trial acronym
ERA 223
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms
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Condition category
Condition code
Cancer
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Radium-223 dichloride (Xofigo, BAY88-8223)
Treatment: Drugs - Matching placebo (normal saline)
Treatment: Drugs - Abiraterone
Treatment: Drugs - Prednisone/Prednisolone
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)
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)
Treatment: Drugs: 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
Treatment: Drugs: Matching placebo (normal saline)
Intravenous injection ( IV-slow bolus), every 4 weeks for 6 cycles
Treatment: Drugs: Abiraterone
1000 mg once daily, oral, with best supportive care
Treatment: Drugs: Prednisone/Prednisolone
5 mg twice daily, oral, with best supportive care
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Symptomatic Skeletal Event Free Survival (SSE-FS)
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Assessment method [1]
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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.
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Timepoint [1]
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From randomization until first onset of on-study symptomatic skeletal event (SSE) or death, up to 47 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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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.
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Timepoint [1]
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From randomization until death from any cause, up to 67 months
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Secondary outcome [2]
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Radiological Progression Free Survival (rPFS)
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Assessment method [2]
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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.
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Timepoint [2]
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From randomization until the date of confirmed radiological progression or death, up to 47 months
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Secondary outcome [3]
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Time to Pain Progression
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Assessment method [3]
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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.
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Timepoint [3]
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From randomization until the date of pain progression based on pain score, up to 47 months
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Secondary outcome [4]
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Time to Cytotoxic Chemotherapy
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Assessment method [4]
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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.
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Timepoint [4]
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From randomization until the date of first cytotoxic chemotherapy, up to 47 months
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Secondary outcome [5]
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Time to Opiate Use for Cancer Pain
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Assessment method [5]
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Time to opiate use for cancer pain was defined as the interval from the date of randomization to the date of opiate use.
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Timepoint [5]
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From randomization until the date of opiate use, up to 47 months
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Secondary outcome [6]
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Number of Participants With Treatment-emergent Adverse Events
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Assessment method [6]
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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.
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Timepoint [6]
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From start of study treatment until the end of the treatment period, up to 65 months
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Secondary outcome [7]
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Number of Subjects With Radium-223/Placebo-related Treatment-emergent Adverse Events Per Maximum Intensity
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Assessment method [7]
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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.
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Timepoint [7]
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From start of study treatment until the end of the treatment period, up to 65 months
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Secondary outcome [8]
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Number of Participants With Any Treatment-emergent Additional Primary Malignancies
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Assessment method [8]
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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.
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Timepoint [8]
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From start of study treatment until 4 weeks after last study treatment, up to 65 months
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Secondary outcome [9]
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Number of Participants With Treatment-emergent Bone Fractures
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Assessment method [9]
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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.
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Timepoint [9]
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From start of study treatment until 4 weeks after last study treatment, up to 65 months
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Secondary outcome [10]
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Number of Participants With Post-treatment Adverse Events
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Assessment method [10]
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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.
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Timepoint [10]
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After the treatment period, up to 46 months
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Secondary outcome [11]
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Number of Participants With Any Study Drug-related Post-treatment Adverse Events Per Maximum Intensity
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Assessment method [11]
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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.
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Timepoint [11]
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After the treatment period, up to 46 months
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Secondary outcome [12]
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Number of Participants With Post-treatment Chemotherapy-related Blood and Lymphatic System Disorders
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Assessment method [12]
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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.
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Timepoint [12]
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After the treatment period, up to 46 months
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Secondary outcome [13]
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Number of Participants With Post-treatment Bone Fractures
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Assessment method [13]
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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.
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Timepoint [13]
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After the treatment period, up to 46 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/03/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/02/2024
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Sample size
Target
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Accrual to date
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Final
806
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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- St Leonards
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Recruitment hospital [2]
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- Adelaide
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Recruitment hospital [3]
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- East Bentleigh
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Recruitment hospital [4]
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- Fitzroy
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- Heidelberg
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Recruitment hospital [6]
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- Darlinghurst
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Recruitment hospital [7]
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- East Melbourne
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Recruitment hospital [8]
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- Randwick
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3165 - East Bentleigh
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Recruitment postcode(s) [4]
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3065 - Fitzroy
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Recruitment postcode(s) [5]
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3084 - Heidelberg
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Recruitment postcode(s) [6]
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2010 - Darlinghurst
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Recruitment postcode(s) [7]
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3002 - East Melbourne
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Recruitment postcode(s) [8]
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2031 - Randwick
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Recruitment outside Australia
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Alaska
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Belgium
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Bruxelles - Brussel
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Bruxelles
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Edegem
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Tampere
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Israel
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Israel
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Kfar Saba
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Israel
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Zrifin
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Italy
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Liguria
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Italy
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Sardegna
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Toscana
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Italy
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Trentino-Alto Adige
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Aichi
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Aomori
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Chiba
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Japan
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Ehime
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Japan
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Hokkaido
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Hyogo
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Ibaraki
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Country [74]
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Japan
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Ishikawa
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Country [75]
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Japan
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Kagawa
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Country [76]
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Japan
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State/province [76]
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Kanagawa
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Country [77]
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Japan
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Miyagi
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Country [78]
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Japan
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State/province [78]
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Nagano
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Country [79]
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Japan
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Okayama
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Country [80]
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Japan
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State/province [80]
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Osaka
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Country [81]
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Japan
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State/province [81]
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Shizuoka
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Country [82]
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Japan
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State/province [82]
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Tokyo
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Country [83]
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Japan
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Yamaguchi
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Country [84]
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Japan
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Fukuoka
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Country [85]
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Japan
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Kumamoto
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Country [86]
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Japan
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Miyazaki
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Country [87]
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Japan
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Nagasaki
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Country [88]
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Netherlands
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Amsterdam
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Country [89]
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Netherlands
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Nijmegen
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Country [90]
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Netherlands
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Zwolle
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Country [91]
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Norway
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State/province [91]
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Bodø
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Country [92]
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Norway
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State/province [92]
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Lørenskog
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Country [93]
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Norway
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Oslo
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Country [94]
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Poland
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Gdansk
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Poland
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Gdynia
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Poland
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Gliwice
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Country [97]
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Poland
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Poznan
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Russian Federation
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Moscow
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Russian Federation
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Obninsk
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Singapore
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Barcelona
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Spain
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Madrid
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Spain
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Pamplona
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Country [106]
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Spain
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State/province [106]
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Sevilla
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Country [107]
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Sweden
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Linköping
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Country [108]
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Sweden
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Stockholm
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Country [109]
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Sweden
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Sundsvall
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Country [110]
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Sweden
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Umea
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Country [111]
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Sweden
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Växjö
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Country [112]
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United Kingdom
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Lothian
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United Kingdom
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Merseyside
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United Kingdom
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Middlesex
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United Kingdom
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Surrey
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Country [116]
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United Kingdom
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Tyne And Wear
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Country [117]
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United Kingdom
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West Midlands
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Country [118]
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United Kingdom
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State/province [118]
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Belfast
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United Kingdom
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Leeds
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Country [120]
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United Kingdom
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London
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United Kingdom
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Romford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Janssen Research & Development, LLC
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02043678
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Public notes
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Contacts
Principal investigator
Name
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0
Bayer Study Director
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Bayer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02043678
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