Back to resultsA Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases (ALSYMPCA)
Primary Purpose
Hormone Refractory Prostate Cancer, Bone Metastases
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Radium-223 dichloride (Xofigo, BAY88-8223)
Placebo
Best standard of care (BSoC)
Sponsored by
About this trial
This is an interventional treatment trial for Hormone Refractory Prostate Cancer focused on measuring Hormone Refractory Prostate Cancer, Bone Metastases, Radium-223
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Known hormone refractory disease
- Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy
- No intention to use cytotoxic chemotherapy within the next 6 months
- Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT (External Beam Radiation Therapy) for bone pain
Exclusion Criteria:
- Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period
- Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available
- Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago
- Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks
- Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
- History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Radium-223 dichloride (Xofigo, BAY88-8223)
Placebo
Arm Description
Participants received radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus Best Standard of Care (BSoC).
Participants received isotonic saline for 6 IV administrations separated by 4 weeks intervals plus Best Standard of Care (BSoC).
Outcomes
Primary Outcome Measures
Overall Survival
Overall survival was defined as the time from date of randomization to the date of death.
Secondary Outcome Measures
Time to Total Alkaline Phosphatase (ALP) Progression
The time from the first study drug administration to when ALP progression was observed, defined as: 1) In subjects with no ALP decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial ALP decline from baseline; the time from start of treatment to first ALP increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later
Percentage of Participants With Total ALP Response at Week 12
ALP levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed total ALP response (either >/= 30% or 50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.
Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)
ALP levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed total ALP response (>/=50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.
Percentage of Participants With Total ALP Normalization at Week 12
The return of total ALP value to within normal range at 12 weeks in 2 consecutive measurements (at least 2 weeks apart) after start of treatment in subjects who had ALP above the upper limit of normal (ULN) at baseline.
Percentage Change From Baseline in Total ALP at Week 12
ALP level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (ALP level at week 12 minus ALP level at baseline)/(ALP level at baseline)*100
Maximum Percentage Decrease From Baseline in Total ALP up to Week 12
ALP level was measured in participant's blood up to week 12 and the maximum percent decrease from the baseline up to Week 12 value was calculated as the minimum value of [(ALP level up to week 12 minus ALP level at baseline)/(ALP level at baseline)*100] by participant, and set to zero if no decrease from baseline.
Percentage Change From Baseline in Total ALP at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)
ALP level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (ALP level at EOT minus ALP level at baseline)/(ALP level at baseline)*100
Maximum Percentage Decrease From Baseline in Total ALP During the 24 Week Treatment
ALP level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 week treatment value was calculated as the minimum value of [(ALP level up to week 24 minus ALP level at baseline)/(ALP level at baseline)*100] by participant, and set to zero if no decrease from baseline.
Time to Prostate Specific Antigen (PSA) Progression
The time from the first study drug administration to when PSA progression was observed, defined as: 1) In subjects with no PSA decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial PSA decline from baseline; the time from start of treatment to first PSA increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later
Percentage of Participants With PSA Response at Week 12
PSA levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed PSA response (>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.
Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)
PSA levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed PSA response (>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.
Percentage Change From Baseline in PSA at Week 12
PSA level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (PSA level at week 12 minus PSA level at baseline)/(PSA level at baseline)*100
Maximum Percentage Decrease From Baseline in PSA up to Week 12
PSA level was measured in participant's blood up to Week 12 and the maximum percent decrease from the baseline up to week 12 value was calculated as the minimum value of [(PSA level up to week 12 minus PSA level at baseline)/(PSA level at baseline)*100] by participant, and set to zero if no decrease from baseline.
Percentage Change From Baseline in PSA at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)
PSA level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (PSA level at EOT minus PSA level at baseline)/(PSA level at baseline)*100
Maximum Percentage Decrease From Baseline in PSA Response During the 24 Week Treatment Period
PSA level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 Week treatment value was calculated as the minimum value of [(PSA level up to week 24 minus PSA level at baseline)/(PSA level at baseline)*100] by participant, and set to zero if no decrease from baseline.
Time to First Skeletal Related Event (SRE)
A skeletal related event is the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumour related orthopaedic surgical intervention. For all other events, the start date of the event/medication/therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time to Occurrence of First Use of External Beam Radiation Therapy (EBRT) to Relieve Skeletal Symptoms
The start date of therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time to Occurrence of First Use of Radioisotopes to Relieve Skeletal Symptoms
The start date of the radioisotopes was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time to Occurrence of First New Symptomatic Pathological Bone Fractures, Vertebral and Non-vertebral
The start date of the event was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time to Occurrence of First Tumor Related Orthopedic Surgical Intervention
The start date of the intervention was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time to Occurrence of First Spinal Cord Compression
The start date of the compression was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time to Occurrence of First Start of Any Other Anti-cancer Treatment
The start date of the treatment was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time to Occurrence of First Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least 2 Points From Baseline
ECOG scores were: 0 = fully active; 1 = restricted in physically strenuous activity; 2 = ambulatory and capable of all self-care but unable to work; 3 = capable of only limited self-care; 4 = completely disabled; 5 = death. The visit at which a 2-point or more deterioration in PS was observed was the time of the event. ECOG was assessed at every visit. If a marked deterioration in PS has not occurred at the time of the analysis or the participant was lost to follow-up, the time-to-event variables were censored at the last assessment date.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00699751
Brief Title
A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases
Acronym
ALSYMPCA
Official Title
A Double-blind, Randomised, Multiple Dose, Phase III, Multicentre Study of Alpharadin in the Treatment of Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.
Detailed Description
The aim of the study was to compare, in patients with symptomatic hormone refractory prostate cancer (HRPC) and skeletal metastases, the efficacy of best standard of care plus Radium-223 dichloride versus best standard of care plus placebo, with the primary efficacy endpoint being overall survival (OS).
Patients were randomised in a 2:1 allocation ratio (Radium-223 dichloride:Placebo). The study treatment consisted of 6 intravenous administrations of Radium-223 dichloride or placebo (saline) each separated by an interval of 4 weeks. The patient were followed until 3 years after first study drug administration.
Within the U.S., the trial was conducted under an IND sponsored by Bayer HealthCare Pharmaceuticals.
All patients received BSoC (Best Standard of Care).
This study has the original PCD as 14 October 2010, when a total of 316 deaths had been observed; this resulted in the Independent Data Monitoring Committee's (IDMC's) recommendation to stop the study as the primary efficacy analysis of overall survival had crossed the pre-specified boundary for efficacy. Later an updated analysis of primary endpoint in the first addendum was done with cut-off of 15 July 2011.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone Refractory Prostate Cancer, Bone Metastases
Keywords
Hormone Refractory Prostate Cancer, Bone Metastases, Radium-223
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
921 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radium-223 dichloride (Xofigo, BAY88-8223)
Arm Type
Experimental
Arm Description
Participants received radium-223 50 kilo Becquerel (kBq)/kg body weight (b.w.) for 6 intravenous (IV) administrations separated by 4 weeks intervals plus Best Standard of Care (BSoC).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received isotonic saline for 6 IV administrations separated by 4 weeks intervals plus Best Standard of Care (BSoC).
Intervention Type
Drug
Intervention Name(s)
Radium-223 dichloride (Xofigo, BAY88-8223)
Other Intervention Name(s)
Alpharadin
Intervention Description
Radium-223 dichloride 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Isotonic saline 6 IV administrations separated by 4 weeks intervals.
Intervention Type
Drug
Intervention Name(s)
Best standard of care (BSoC)
Intervention Description
Best standard of care is regarded as the routine standard of care at each center, for example local EBRT (External Beam Radiation Therapy), corticosteroids, antiandrogens, estrogens (e.g., stilboestrol), estramustine or ketoconazole.
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival was defined as the time from date of randomization to the date of death.
Time Frame
From randomization to death due to any cause until approximately 3 years after start of enrollment, the data was collected up to the second data analysis date (15 JUL 2011)
Secondary Outcome Measure Information:
Title
Time to Total Alkaline Phosphatase (ALP) Progression
Description
The time from the first study drug administration to when ALP progression was observed, defined as: 1) In subjects with no ALP decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial ALP decline from baseline; the time from start of treatment to first ALP increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later
Time Frame
From randomization to first ALP progression until approximately 3 years after start of enrollment
Title
Percentage of Participants With Total ALP Response at Week 12
Description
ALP levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed total ALP response (either >/= 30% or 50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.
Time Frame
At Baseline and Week 12
Title
Percentage of Participants With Total ALP Response at End of Treatment (EOT; Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)
Description
ALP levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed total ALP response (>/=50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.
Time Frame
At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
Title
Percentage of Participants With Total ALP Normalization at Week 12
Description
The return of total ALP value to within normal range at 12 weeks in 2 consecutive measurements (at least 2 weeks apart) after start of treatment in subjects who had ALP above the upper limit of normal (ULN) at baseline.
Time Frame
At Baseline and Week 12
Title
Percentage Change From Baseline in Total ALP at Week 12
Description
ALP level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (ALP level at week 12 minus ALP level at baseline)/(ALP level at baseline)*100
Time Frame
At Baseline and Week 12
Title
Maximum Percentage Decrease From Baseline in Total ALP up to Week 12
Description
ALP level was measured in participant's blood up to week 12 and the maximum percent decrease from the baseline up to Week 12 value was calculated as the minimum value of [(ALP level up to week 12 minus ALP level at baseline)/(ALP level at baseline)*100] by participant, and set to zero if no decrease from baseline.
Time Frame
From baseline to Week 12
Title
Percentage Change From Baseline in Total ALP at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)
Description
ALP level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (ALP level at EOT minus ALP level at baseline)/(ALP level at baseline)*100
Time Frame
At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
Title
Maximum Percentage Decrease From Baseline in Total ALP During the 24 Week Treatment
Description
ALP level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 week treatment value was calculated as the minimum value of [(ALP level up to week 24 minus ALP level at baseline)/(ALP level at baseline)*100] by participant, and set to zero if no decrease from baseline.
Time Frame
From baseline During the 24 Week Treatment
Title
Time to Prostate Specific Antigen (PSA) Progression
Description
The time from the first study drug administration to when PSA progression was observed, defined as: 1) In subjects with no PSA decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial PSA decline from baseline; the time from start of treatment to first PSA increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks later
Time Frame
From randomization to first PSA progression until approximately 3 years after start of enrollment
Title
Percentage of Participants With PSA Response at Week 12
Description
PSA levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed PSA response (>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.
Time Frame
At Baseline and Week 12
Title
Percentage of Participants With PSA Response at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)
Description
PSA levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed PSA response (>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.
Time Frame
At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
Title
Percentage Change From Baseline in PSA at Week 12
Description
PSA level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (PSA level at week 12 minus PSA level at baseline)/(PSA level at baseline)*100
Time Frame
At Baseline and Week 12
Title
Maximum Percentage Decrease From Baseline in PSA up to Week 12
Description
PSA level was measured in participant's blood up to Week 12 and the maximum percent decrease from the baseline up to week 12 value was calculated as the minimum value of [(PSA level up to week 12 minus PSA level at baseline)/(PSA level at baseline)*100] by participant, and set to zero if no decrease from baseline.
Time Frame
From baseline up to Week 12
Title
Percentage Change From Baseline in PSA at EOT (Week 24 or at the Time the Patient Dies or Discontinues Treatment Phase)
Description
PSA level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (PSA level at EOT minus PSA level at baseline)/(PSA level at baseline)*100
Time Frame
At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
Title
Maximum Percentage Decrease From Baseline in PSA Response During the 24 Week Treatment Period
Description
PSA level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 Week treatment value was calculated as the minimum value of [(PSA level up to week 24 minus PSA level at baseline)/(PSA level at baseline)*100] by participant, and set to zero if no decrease from baseline.
Time Frame
From baseline to End of Treatment (Week 24; 4 weeks post last injection)
Title
Time to First Skeletal Related Event (SRE)
Description
A skeletal related event is the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumour related orthopaedic surgical intervention. For all other events, the start date of the event/medication/therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time Frame
From randomization to first first SRE until approximately 3 years after start of enrollment
Title
Time to Occurrence of First Use of External Beam Radiation Therapy (EBRT) to Relieve Skeletal Symptoms
Description
The start date of therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time Frame
From randomization to first EBRT until approximately 3 years after start of enrollment
Title
Time to Occurrence of First Use of Radioisotopes to Relieve Skeletal Symptoms
Description
The start date of the radioisotopes was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time Frame
From randomization to first use of radioisotopes until approximately 3 years after start of enrollment
Title
Time to Occurrence of First New Symptomatic Pathological Bone Fractures, Vertebral and Non-vertebral
Description
The start date of the event was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time Frame
From randomization to occurrence of first new symptomatic pathological bone fractures until approximately 3 years after start of enrollment
Title
Time to Occurrence of First Tumor Related Orthopedic Surgical Intervention
Description
The start date of the intervention was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time Frame
From randomization to occurrence of first tumor related orthopedic surgical intervention until approximately 3 years after start of enrollment
Title
Time to Occurrence of First Spinal Cord Compression
Description
The start date of the compression was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time Frame
From randomization to first spinal cord compression until approximately 3 years after start of enrollment
Title
Time to Occurrence of First Start of Any Other Anti-cancer Treatment
Description
The start date of the treatment was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.
Time Frame
From randomization to first start of any other anti-cancer treatment until approximately 3 years after start of enrollment
Title
Time to Occurrence of First Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least 2 Points From Baseline
Description
ECOG scores were: 0 = fully active; 1 = restricted in physically strenuous activity; 2 = ambulatory and capable of all self-care but unable to work; 3 = capable of only limited self-care; 4 = completely disabled; 5 = death. The visit at which a 2-point or more deterioration in PS was observed was the time of the event. ECOG was assessed at every visit. If a marked deterioration in PS has not occurred at the time of the analysis or the participant was lost to follow-up, the time-to-event variables were censored at the last assessment date.
Time Frame
From randomization to first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) until approximately 3 years after start of enrollment
Other Pre-specified Outcome Measures:
Title
Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 0.
Description
ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.
Time Frame
Week 0
Title
Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 8.
Description
ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.
Time Frame
Week 8
Title
Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 16.
Description
ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.
Time Frame
Week 16
Title
Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Week 24.
Description
ECOG PS was defined as: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (eg, light house work, office work); 2 = Ambulatory and capable of all self-care but unable to carry out work activities. Up and about > 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair > 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; or 5 = Dead.
Time Frame
Week 24
Title
Absolute Scores for Functional Assessment of Cancer Therapy - Prostate (FACT-P) Trial Outcome Index (TOI)
Description
The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated for each visit. Prostate Cancer Trial Outcome Index (TOI): Physical Well-being (PWB) + Functional Well-being (FWB) + Prostate Cancer (PCS). Score ranges from 0 (worst) to 104 (best).
Time Frame
Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)
Title
Changes From Baseline for FACT-P Trial Outcome Index (TOI) at Week 16, Week 24, and Follow-up Visit 2 (Week 42)
Description
The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score for the FACT-P TOI domain (physical and social well-being and prostate specific score) was calculated for each visit. Possible scores were 0 to 104; the higher the score, the better the quality of life. The changes from baseline (range -104 to 104) in the domain FACT-P TOI were summarized using descriptive statistics at Week 16, Week 24, and Follow-up Visit 2.
Time Frame
Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)
Title
Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 16
Description
The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 - Not at all; 4 - Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Week 16.
Time Frame
At Week 16
Title
Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Week 24
Description
The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 - Not at all; 4 - Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Week 24.
Time Frame
At Week 24
Title
Absolute Scores for Physical Well Being, Social/Family Well Being, Emotional Well Being, Functional Well Being, and the Prostate Cancer Subscale at Follow-up Visit 2 (Week 42)
Description
The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being and was supplemented by 12 questions relating to prostate cancer. Possible scores for each subscale were 0 to 28; 0 to 28; 0 to 24; 0 to 28; and 0 to 48, respectively. All FACT-P items are scored on a scale of 0-4 representing the extent to which the item reflects the experience of the individual completing the instrument (0 - Not at all; 4 - Very much). Higher scores indicate better quality of life. The absolute score of the FACT-P total score was calculated at Follow-up Visit 2.
Time Frame
At Follow-up Visit 2 (Week 42)
Title
Absolute Scores for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)
Description
The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. The absolute score of the FACT-P total score (physical, social/family, emotional, and functional well-being and prostate specific score) was calculated at Week 16, Week 24, and Follow-up Visit 2.FACT-P Total Score: Physical Well-being (PWB) + Social/Family Well-being (SWB) + Emotional Well-being (EWB) + Functional Well-being (FWB) + Prostate Cancer (PCS). Score ranges from 0 (worst) to 156 (best).
Time Frame
At Week 16, Week 24, and Follow-up Visit 2 (Week 42)
Title
Change From Baseline for FACT-P Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)
Description
The FACT-P was 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. It was supplemented by 12 questions relating to prostate cancer. Total possible score was 156; a higher score indicates a better quality of life. The changes from baseline in the FACT-P total score (physical, social/family, emotional, and functional well-being and prostate specific score) were calculated at Week 16, Week 24, and Follow-up Visit 2. Possible range was -156 to 156.
Time Frame
Baseline, Week 16, Week 24, and Follow-up Visit 2 (week 42)
Title
Absolute Scores for Functional Assessment of Cancer Therapy - General (FACT-G) Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)
Description
The FACT-G instrument consisted of 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. The FACT-G absolute total score (physical, social/family, emotional, and functional well-being) was calculated at Week 16, Week 24, and Follow-up Visit 2. FACT-G Total Score: Physical Well-being (PWB) + Social/Family Well-being (SWB) + Emotional Well-being (EWB) + Functional Well-being (FWB). Score ranges from 0 (worst) to 108 (best).
Time Frame
At Week 16, Week 24, and Follow-up Visit 2 (Week 42)
Title
Change From Baseline for FACT-G Total Score at Week 16, Week 24, and Follow-up Visit 2 (Week 42)
Description
The FACT-G instrument consisted of 27 questions relating to 4 domains: physical, social/family, emotional, and functional well-being. Total possible score was 108; a higher score indicates a better quality of life. The changes from baseline in the FACT-G total score (physical, social/family, emotional, and functional well-being) were calculated at Week 16, Week 24, and Follow-up Visit 2. Possible range was -108 to 108.
Time Frame
Baseline, Week 16, Week 24, and Follow-up Visit 2 (Week 42)
Title
Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 16
Description
The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at Week 16, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems').
Time Frame
Week 16
Title
Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Week 24
Description
The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at Week 24, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems').
Time Frame
Week 24
Title
Number of Participants in the Euro Quality of Life (EQ-5D) Components for Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression at Follow-up Visit 8 (Week 139)
Description
The EQ-5D questionnaire was given to the subject at each visit. The EQ-5D questionnaire consisted of 5 ordinal categorical responses (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Number of participants with EQ-5D at follow-up visit 8, as measured by this questionnaire, was counted. The scores for the EQ-5D dimensions are assigned according to the level of problems reported (1 'no problems'; 2 'some problems'; 3 'extreme problems').
Time Frame
Follow-up Visit 8 (Week 139)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the prostate
Known hormone refractory disease
Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy
No intention to use cytotoxic chemotherapy within the next 6 months
Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT (External Beam Radiation Therapy) for bone pain
Exclusion Criteria:
Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period
Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available
Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago
Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks
Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Parker, MD
Organizational Affiliation
The Royal Marsden Hospital, UK
Official's Role
Study Chair
Facility Information:
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048-0750
Country
United States
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2521
Country
Australia
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
City
Toowoomba
State/Province
Queensland
ZIP/Postal Code
4350
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41830-492
Country
Brazil
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30110-090
Country
Brazil
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784400
Country
Brazil
City
Piracicaba
State/Province
Sao Paulo
Country
Brazil
City
Belo Horizonte
ZIP/Postal Code
30380490
Country
Brazil
City
Rio de Janeiro
ZIP/Postal Code
20551 030
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
05403-900
Country
Brazil
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
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
Brno
ZIP/Postal Code
65653
Country
Czech Republic
City
Chomutov
ZIP/Postal Code
430 12
Country
Czech Republic
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
City
Ostrava
ZIP/Postal Code
708 52
Country
Czech Republic
City
Plzen - Bory
ZIP/Postal Code
305 99
Country
Czech Republic
City
Praha 4
ZIP/Postal Code
140 59
Country
Czech Republic
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
City
Montbeliard
ZIP/Postal Code
25209
Country
France
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89075
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35043
Country
Germany
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37099
Country
Germany
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
City
Dortmund
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44137
Country
Germany
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
City
Berlin
ZIP/Postal Code
10967
Country
Germany
City
Berlin
ZIP/Postal Code
14197
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Chai Wan
Country
Hong Kong
City
Hong Kong
Country
Hong Kong
City
Hongkong
Country
Hong Kong
City
Kowloon
Country
Hong Kong
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
City
Zrifin
ZIP/Postal Code
6093000
Country
Israel
City
Meldola
State/Province
Forlì
ZIP/Postal Code
47014
Country
Italy
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
City
Milano
ZIP/Postal Code
20162
Country
Italy
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
City
Bergen
ZIP/Postal Code
5021
Country
Norway
City
Bodø
ZIP/Postal Code
8092
Country
Norway
City
Kristiansand
ZIP/Postal Code
N-4604
Country
Norway
City
Oslo
ZIP/Postal Code
0450
Country
Norway
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway
City
Tromsø
ZIP/Postal Code
9038
Country
Norway
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
City
Ålesund
ZIP/Postal Code
6026
Country
Norway
City
Bydgoszcz
ZIP/Postal Code
85-165
Country
Poland
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
City
Kielce
ZIP/Postal Code
25-734
Country
Poland
City
Krakow
ZIP/Postal Code
31-051
Country
Poland
City
Luiblin
ZIP/Postal Code
20-954
Country
Poland
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
City
Wroclaw
ZIP/Postal Code
50 - 556
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
City
Singapore
ZIP/Postal Code
258499
Country
Singapore
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
City
Banska Bystrica
ZIP/Postal Code
97517
Country
Slovakia
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
City
Bratislava
ZIP/Postal Code
83305
Country
Slovakia
City
Martin
ZIP/Postal Code
03659
Country
Slovakia
City
Presov
ZIP/Postal Code
08181
Country
Slovakia
City
Trnava
ZIP/Postal Code
917 01
Country
Slovakia
City
Santiago de Compostela
State/Province
A Coruña
ZIP/Postal Code
15706
Country
Spain
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
City
Valencia
ZIP/Postal Code
46026
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
City
Jönköping
ZIP/Postal Code
551 85
Country
Sweden
City
Kalmar
ZIP/Postal Code
391 85
Country
Sweden
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
City
Sandviken
ZIP/Postal Code
80187
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
Romford
State/Province
Essex
ZIP/Postal Code
RM7 0AG
Country
United Kingdom
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
City
Bebington
State/Province
Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
City
Taunton
State/Province
Somerset
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
City
Ipswich
State/Province
Suffolk
ZIP/Postal Code
IP4 5PD
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
Coventry
State/Province
Warwickshire
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
City
Brighton
ZIP/Postal Code
BN2 5BD
Country
United Kingdom
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
City
Cardiff
Country
United Kingdom
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
City
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
City
Sheffield
ZIP/Postal Code
S10 2SJ
Country
United Kingdom
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23863050
Citation
Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzen L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland OS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. doi: 10.1056/NEJMoa1213755.
Results Reference
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Citation
Hoskin P, Sartor O, O'Sullivan JM, Johannessen DC, Helle SI, Logue J, Bottomley D, Nilsson S, Vogelzang NJ, Fang F, Wahba M, Aksnes AK, Parker C. Efficacy and safety of radium-223 dichloride in patients with castration-resistant prostate cancer and symptomatic bone metastases, with or without previous docetaxel use: a prespecified subgroup analysis from the randomised, double-blind, phase 3 ALSYMPCA trial. Lancet Oncol. 2014 Nov;15(12):1397-406. doi: 10.1016/S1470-2045(14)70474-7. Epub 2014 Oct 17.
Results Reference
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PubMed Identifier
24836273
Citation
Sartor O, Coleman R, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, Chodacki A, Wiechno P, Logue J, Widmark A, Johannessen DC, Hoskin P, James ND, Solberg A, Syndikus I, Vogelzang NJ, O'Bryan-Tear CG, Shan M, Bruland OS, Parker C. Effect of radium-223 dichloride on symptomatic skeletal events in patients with castration-resistant prostate cancer and bone metastases: results from a phase 3, double-blind, randomised trial. Lancet Oncol. 2014 Jun;15(7):738-46. doi: 10.1016/S1470-2045(14)70183-4. Epub 2014 May 13.
Results Reference
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PubMed Identifier
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Citation
Delacruz A, Arauz G, Curley T, Lindo A, Jensen T. Nursing management of patients with castration-resistant prostate cancer undergoing radium-223 dichloride treatment. Clin J Oncol Nurs. 2015 Apr;19(2):E31-5. doi: 10.1188/15.CJON.E31-E35.
Results Reference
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PubMed Identifier
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Citation
Humm JL, Sartor O, Parker C, Bruland OS, Macklis R. Radium-223 in the treatment of osteoblastic metastases: a critical clinical review. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):898-906. doi: 10.1016/j.ijrobp.2014.12.061.
Results Reference
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PubMed Identifier
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Citation
Nilsson S. Alpha-emitter radium-223 in the management of solid tumors: current status and future directions. Am Soc Clin Oncol Educ Book. 2014:e132-9. doi: 10.14694/EdBook_AM.2014.34.e132.
Results Reference
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PubMed Identifier
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Citation
Den RB, Doyle LA, Knudsen KE. Practical guide to the use of radium 223 dichloride. Can J Urol. 2014 Apr;21(2 Supp 1):70-6.
Results Reference
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PubMed Identifier
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Citation
Shirley M, McCormack PL. Radium-223 dichloride: a review of its use in patients with castration-resistant prostate cancer with symptomatic bone metastases. Drugs. 2014 Apr;74(5):579-86. doi: 10.1007/s40265-014-0198-4.
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PubMed Identifier
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Citation
Wissing MD, van Leeuwen FW, van der Pluijm G, Gelderblom H. Radium-223 chloride: Extending life in prostate cancer patients by treating bone metastases. Clin Cancer Res. 2013 Nov 1;19(21):5822-7. doi: 10.1158/1078-0432.CCR-13-1896. Epub 2013 Sep 19.
Results Reference
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Citation
Joung JY, Ha YS, Kim IY. Radium Ra 223 dichloride in castration-resistant prostate cancer. Drugs Today (Barc). 2013 Aug;49(8):483-90. doi: 10.1358/dot.2013.49.8.1968670.
Results Reference
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Results Reference
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Links:
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
A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases
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