Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000262202
Ethics application status
Approved
Date submitted
20/02/2009
Date registered
14/05/2009
Date last updated
17/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public 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
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, with the primary efficacy endpoint being overall survival.
Secondary ID [1] 812 0
ClinicalTrials.gov: NCT00699751
Universal Trial Number (UTN)
Trial acronym
ALSYMPCA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone refractory prostate cancer 4355 0
Bone metastases 4366 0
Condition category
Condition code
Cancer 4611 4611 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug: Radium-223 dichloride 50 kBq/kg body weight (b.w.), 6 intravenous (IV) administrations separated by 4 weeks intervals
Intervention code [1] 4088 0
Treatment: Drugs
Comparator / control treatment
Placebo:
Isotonic saline 6 intravenous (IV) administrations separated by 4 weeks intervals
Control group
Placebo

Outcomes
Primary outcome [1] 5477 0
Overall survival
Timepoint [1] 5477 0
Time from date of randomisation to the date of event
Secondary outcome [1] 9219 0
Time to occurrence of specific disease events: use of external beam radiotherapy to relieve skeletal symptoms, use of radio-isotopes, bone fractures, orthopedic surgical interventions, spinal cord compression, other anti-cancer treatment, Eastern Cooperative Oncology Group (ECOG) performance status
Timepoint [1] 9219 0
Time to first on-study specific disease events
Secondary outcome [2] 9220 0
Changes and time to progression in prostate-specific antigen (PSA), measured by blood analysis
Timepoint [2] 9220 0
Study duration:
Screening; Treatment period: week 0, 4, 8, 12, 16, 20, 24; Follow-up period: Every 2 months starting from week 24 up until week 52, every 4 months starting from week 52 up until 3 years
Secondary outcome [3] 9221 0
Changes and time to progression in total alkaline phosphatase (ALP), measured by blood analysis
Timepoint [3] 9221 0
Study duration: Screening; Treatment period: Treatment period: week 0, 4, 8, 12, 16, 20, 24; Follow-up period: Every 2 months starting from week 24 up until week 52, every 4 months starting from week 52 up until 3 years
Secondary outcome [4] 9222 0
Safety endpoints; Adverse events, laboratory values, potential manifestations of late toxicity
Timepoint [4] 9222 0
Study duration: Monthly during the 6-month treatment period, Follow-up period: Every 2 months starting from week 24 up until week 52, every 4 months starting from week 52 up until 3 years
Secondary outcome [5] 9223 0
Clinical benefit endpoints: Performance status, Health related Quality of Life
QoL FACT-P & QoL EQ5D forms
Timepoint [5] 9223 0
Study duration:
QoL FACT-P form: Week 0, 16, 24
Month 10
QoL EQ5D forms:
Week 0, 16, 24
Follow-up period: Every 2 months starting from week 24 up until week 52, every 4 months starting from week 52 up until 3 years

Eligibility
Key inclusion criteria
Histologically or cytologically confirmed adenocarcinoma of the prostate - Known hormone refractory disease - Multiple skeletal metastases (greater than or equal to 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 external beam radiation therapy (EBRT) 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 computed tomography (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?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
17/06/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
921
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA,TAS
Recruitment outside Australia
Country [1] 1576 0
Belgium
State/province [1] 1576 0
Country [2] 1577 0
Brazil
State/province [2] 1577 0
Country [3] 1578 0
Canada
State/province [3] 1578 0
Country [4] 1579 0
Czech Republic
State/province [4] 1579 0
Country [5] 1580 0
France
State/province [5] 1580 0
Country [6] 1581 0
Germany
State/province [6] 1581 0
Country [7] 1582 0
Hong Kong
State/province [7] 1582 0
Country [8] 1583 0
Italy
State/province [8] 1583 0
Country [9] 1584 0
Netherlands
State/province [9] 1584 0
Country [10] 1585 0
Norway
State/province [10] 1585 0
Country [11] 1586 0
Poland
State/province [11] 1586 0
Country [12] 1587 0
Singapore
State/province [12] 1587 0
Country [13] 1588 0
Spain
State/province [13] 1588 0
Country [14] 1589 0
Slovakia
State/province [14] 1589 0
Country [15] 1590 0
Sweden
State/province [15] 1590 0
Country [16] 1591 0
United Kingdom
State/province [16] 1591 0
Country [17] 1592 0
Israel
State/province [17] 1592 0
Country [18] 1593 0
United States of America
State/province [18] 1593 0

Funding & Sponsors
Funding source category [1] 4541 0
Commercial sector/Industry
Name [1] 4541 0
Algeta ASA
Country [1] 4541 0
Norway
Primary sponsor type
Commercial sector/Industry
Name
Algeta ASA
Address
P.O. Box 54 Kjelsaas
0411
Country
Norway
Secondary sponsor category [1] 4096 0
Commercial sector/Industry
Name [1] 4096 0
Bayer HealthCare Pharmaceuticals Inc.
Address [1] 4096 0
Muellerstrasse 178, 13353 Berlin
Country [1] 4096 0
Germany

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Alsympca 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.

The aim of the study is to compare, in patients with symptomatic 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 will be randomised in a 2:1 allocation ratio (Radium-223 dichloride:Placebo). The study treatment consists of 6 intravenous administrations of Radium-223 dichloride or placebo (saline) each separated by an interval of 4 weeks. The patient will be followed until 3 years after first study drug administration. Within the U.S., the trial is conducted under an IND sponsored by Bayer HealthCare Pharmaceuticals. All patients received BSoC (Best Standard of Care)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29307 0
Address 29307 0
Country 29307 0
Phone 29307 0
Fax 29307 0
Email 29307 0
Contact person for public queries
Name 12554 0
Karin Staudacher
Address 12554 0
Algeta ASA
P.O. Box 54 Kjelsaas
0411 Oslo
Country 12554 0
Norway
Phone 12554 0
+4723007990
Fax 12554 0
Email 12554 0
[email protected]
Contact person for scientific queries
Name 3482 0
Karin Staudacher
Address 3482 0
Algeta ASA
P.O. Box 54 Kjelsaas
0411 Oslo
Country 3482 0
Norway
Phone 3482 0
+4723007990
Fax 3482 0
Email 3482 0
[email protected]

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

Documents added manually
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