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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00699751




Registration number
NCT00699751
Ethics application status
Date submitted
17/06/2008
Date registered
18/06/2008
Date last updated
27/05/2016

Titles & IDs
Public title
A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases
Scientific 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
Secondary ID [1] 0 0
BC1-06
Secondary ID [2] 0 0
15245
Universal Trial Number (UTN)
Trial acronym
ALSYMPCA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone Refractory Prostate Cancer 0 0
Bone Metastases 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Radium-223 dichloride (Xofigo, BAY88-8223)
Treatment: Drugs - Placebo
Treatment: Drugs - Best standard of care (BSoC)

Experimental: Radium-223 dichloride (Xofigo, BAY88-8223) - 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).

Placebo Comparator: Placebo - Participants received isotonic saline for 6 IV administrations separated by 4 weeks intervals plus Best Standard of Care (BSoC).


Treatment: Drugs: Radium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride 50 kBq/kg b.w., 6 IV administrations separated by 4 weeks intervals.

Treatment: Drugs: Placebo
Isotonic saline 6 IV administrations separated by 4 weeks intervals.

Treatment: Drugs: Best standard of care (BSoC)
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival - Overall survival was defined as the time from date of randomization to the date of death.
Timepoint [1] 0 0
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 [1] 0 0
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
Timepoint [1] 0 0
From randomization to first ALP progression until approximately 3 years after start of enrollment
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
At Baseline and Week 12
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
At Baseline and Week 12
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
At Baseline and Week 12
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
From baseline to Week 12
Secondary outcome [7] 0 0
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
Timepoint [7] 0 0
At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
From baseline During the 24 Week Treatment
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
From randomization to first PSA progression until approximately 3 years after start of enrollment
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
At Baseline and Week 12
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
At Baseline and Week 12
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
From baseline up to Week 12
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
Secondary outcome [15] 0 0
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.
Timepoint [15] 0 0
From baseline to End of Treatment (Week 24; 4 weeks post last injection)
Secondary outcome [16] 0 0
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.
Timepoint [16] 0 0
From randomization to first first SRE until approximately 3 years after start of enrollment
Secondary outcome [17] 0 0
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.
Timepoint [17] 0 0
From randomization to first EBRT until approximately 3 years after start of enrollment
Secondary outcome [18] 0 0
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.
Timepoint [18] 0 0
From randomization to first use of radioisotopes until approximately 3 years after start of enrollment
Secondary outcome [19] 0 0
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.
Timepoint [19] 0 0
From randomization to occurrence of first new symptomatic pathological bone fractures until approximately 3 years after start of enrollment
Secondary outcome [20] 0 0
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.
Timepoint [20] 0 0
From randomization to occurrence of first tumor related orthopedic surgical intervention until approximately 3 years after start of enrollment
Secondary outcome [21] 0 0
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.
Timepoint [21] 0 0
From randomization to first spinal cord compression until approximately 3 years after start of enrollment
Secondary outcome [22] 0 0
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.
Timepoint [22] 0 0
From randomization to first start of any other anti-cancer treatment until approximately 3 years after start of enrollment
Secondary outcome [23] 0 0
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.
Timepoint [23] 0 0
From randomization to first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) until approximately 3 years after start of enrollment

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Liverpool
Recruitment hospital [2] 0 0
- Randwick
Recruitment hospital [3] 0 0
- St Leonards
Recruitment hospital [4] 0 0
- Sydney
Recruitment hospital [5] 0 0
- Wahroonga
Recruitment hospital [6] 0 0
- Wollongong
Recruitment hospital [7] 0 0
- Brisbane
Recruitment hospital [8] 0 0
- Toowoomba
Recruitment hospital [9] 0 0
- Adelaide
Recruitment hospital [10] 0 0
- Hobart
Recruitment hospital [11] 0 0
- Fitzroy
Recruitment hospital [12] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment postcode(s) [5] 0 0
2076 - Wahroonga
Recruitment postcode(s) [6] 0 0
2521 - Wollongong
Recruitment postcode(s) [7] 0 0
4029 - Brisbane
Recruitment postcode(s) [8] 0 0
4350 - Toowoomba
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
5011 - Adelaide
Recruitment postcode(s) [11] 0 0
7000 - Hobart
Recruitment postcode(s) [12] 0 0
3065 - Fitzroy
Recruitment postcode(s) [13] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Florida
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United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Nevada
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
Belgium
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Kortrijk
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Belgium
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Ottignies
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Brazil
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Bahia
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Minas Gerais
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Brazil
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Rio Grande do Sul
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Brazil
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Sao Paulo
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Brazil
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Belo Horizonte
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Brazil
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Rio de Janeiro
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Canada
State/province [15] 0 0
Alberta
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Canada
State/province [16] 0 0
Ontario
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Czech Republic
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Brno
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Czech Republic
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Chomutov
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Czech Republic
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Olomouc
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Czech Republic
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Ostrava
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Czech Republic
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Plzen - Bory
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Czech Republic
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Praha 4
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Czech Republic
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Usti nad Labem
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France
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La Roche Sur Yon
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France
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Montbeliard
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France
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Saint Cloud
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Germany
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Baden-Württemberg
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Germany
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Hessen
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Germany
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Niedersachsen
Country [30] 0 0
Germany
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
State/province [32] 0 0
Berlin
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Germany
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Hamburg
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Hong Kong
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Chai Wan
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Hong Kong
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Hong Kong
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Hong Kong
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Hongkong
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Hong Kong
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Kowloon
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Israel
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Beer Sheva
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Israel
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Kfar Saba
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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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Forlì
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Italy
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Torino
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Italy
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Bergamo
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Italy
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Milano
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Italy
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Reggio Emilia
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Netherlands
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Alkmaar
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Netherlands
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Nijmegen
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Netherlands
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Rotterdam
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Norway
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Bergen
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Norway
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Norway
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Kristiansand
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Oslo
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Norway
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Tromsø
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Norway
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Trondheim
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Norway
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Ålesund
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Poland
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Bydgoszcz
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Gliwice
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Kielce
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Krakow
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Luiblin
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Warszawa
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Wroclaw
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Singapore
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Singapore
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Slovakia
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Martin
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Slovakia
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Presov
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Slovakia
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Trnava
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A Coruña
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Madrid
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Spain
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Vizcaya
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Barcelona
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Spain
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Córdoba
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Spain
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Pamplona
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Spain
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Valencia
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Spain
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Zaragoza
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Sweden
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Göteborg
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Sweden
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Jönköping
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Sweden
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Kalmar
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Sweden
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Malmö
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Sweden
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Sandviken
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Sweden
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Stockholm
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Sweden
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Sundsvall
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Sweden
State/province [85] 0 0
Umeå
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United Kingdom
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Essex
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United Kingdom
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Leicestershire
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United Kingdom
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Merseyside
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United Kingdom
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Nottinghamshire
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United Kingdom
State/province [90] 0 0
Somerset
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United Kingdom
State/province [91] 0 0
Suffolk
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Surrey
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United Kingdom
State/province [93] 0 0
Warwickshire
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United Kingdom
State/province [94] 0 0
West Midlands
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Belfast
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Brighton
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Bristol
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Cardiff
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Derby
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Hull
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Leeds
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Manchester
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Northwood
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Plymouth
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Sheffield
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Southampton
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00699751
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Parker, MD
Address 0 0
The Royal Marsden Hospital, UK
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications