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Trial details imported from ClinicalTrials.gov

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

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
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
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
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)
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
Timepoint [4] 0 0
At Baseline and Week 12
Secondary outcome [5] 0 0
Percentage Change From Baseline in Total ALP at Week 12
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
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)
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
Timepoint [8] 0 0
From baseline During the 24 Week Treatment
Secondary outcome [9] 0 0
Time to Prostate Specific Antigen (PSA) Progression
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
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)
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
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
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)
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
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)
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
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
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
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
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
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
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
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
Sex
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
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2014
Sample size
Target
Accrual to date
Final
921
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
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
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
State/province [7] 0 0
Kortrijk
Country [8] 0 0
Belgium
State/province [8] 0 0
Ottignies
Country [9] 0 0
Brazil
State/province [9] 0 0
Bahia
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Brazil
State/province [10] 0 0
Minas Gerais
Country [11] 0 0
Brazil
State/province [11] 0 0
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
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Brno
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Czech Republic
State/province [18] 0 0
Chomutov
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Olomouc
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Ostrava
Country [21] 0 0
Czech Republic
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Plzen - Bory
Country [22] 0 0
Czech Republic
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Praha 4
Country [23] 0 0
Czech Republic
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Usti nad Labem
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France
State/province [24] 0 0
La Roche Sur Yon
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France
State/province [25] 0 0
Montbeliard
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France
State/province [26] 0 0
Saint Cloud
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Germany
State/province [27] 0 0
Baden-Württemberg
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Germany
State/province [28] 0 0
Hessen
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Germany
State/province [29] 0 0
Niedersachsen
Country [30] 0 0
Germany
State/province [30] 0 0
Nordrhein-Westfalen
Country [31] 0 0
Germany
State/province [31] 0 0
Rheinland-Pfalz
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Germany
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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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Nijmegen
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Rotterdam
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Bergen
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Bodø
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Norway
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Kristiansand
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Oslo
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Tromsø
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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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Wroclaw
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Singapore
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Banska Bystrica
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Bratislava
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Martin
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Presov
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Trnava
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Vizcaya
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Barcelona
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Córdoba
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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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Kalmar
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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
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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
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Somerset
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United Kingdom
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Suffolk
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United Kingdom
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Surrey
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United Kingdom
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Warwickshire
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United Kingdom
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West Midlands
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United Kingdom
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Belfast
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United Kingdom
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Brighton
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United Kingdom
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Bristol
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United Kingdom
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Cardiff
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United Kingdom
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Derby
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United Kingdom
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Hull
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United Kingdom
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Leeds
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United Kingdom
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Manchester
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United Kingdom
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Northwood
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United Kingdom
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Plymouth
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United Kingdom
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Sheffield
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United Kingdom
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Southampton
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United Kingdom
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Wolverhampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Parker C, Nilsson S, Heinrich D, Helle SI, O'Sulli... [More Details]
Journal Hoskin P, Sartor O, O'Sullivan JM, Johannessen DC,... [More Details]
Journal Sartor O, Coleman R, Nilsson S, Heinrich D, Helle ... [More Details]
Journal Delacruz A, Arauz G, Curley T, Lindo A, Jensen T. ... [More Details]
Journal Humm JL, Sartor O, Parker C, Bruland OS, Macklis R... [More Details]
Journal Nilsson S. Alpha-emitter radium-223 in the managem... [More Details]
Journal Den RB, Doyle LA, Knudsen KE. Practical guide to t... [More Details]
Journal Shirley M, McCormack PL. Radium-223 dichloride: a ... [More Details]
Journal Wissing MD, van Leeuwen FW, van der Pluijm G, Geld... [More Details]
Journal Joung JY, Ha YS, Kim IY. Radium Ra 223 dichloride ... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00699751