- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00459654
A Placebo-controlled Phase II Study of Bone-targeted Radium-223 in Symptomatic Hormone-refractory Prostate Cancer
June 24, 2014 updated by: Bayer
A Phase II Randomised, Placebo-controlled, Multicentre Study in Prostate Cancer Patients With Painful Bone Metastases to Evaluate the Efficacy of Repeated Radium-223 Injections
The purpose of this study is to evaluate the effectiveness of the investigational radioisotope Radium-223 in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Primary objective:
To study the biological effectiveness of radium-223 therapy measured as:
- Time to occurrence of skeletal-related events(SREs)
- Change in bone-specific alkaline phosphatase (bone-ALP) levels
Secondary objectives:
To study the efficacy of radium-223 therapy in terms of:
- Frequency of new SREs
- Proportions of patients with an SRE
- Proportions of patients with SRE at different time points
- Changes of biochemical markers of bone turnover
- Treatment response with regard to pain and analgesic use(termed "Palliative effect" in study protocol)
- Quality of life assessment
- Overall survival To study the safety of the repeated radium-223 regimen Total Enrollment:64 Study start: February 2004
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Linköping, Sweden
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Sundsvall, Sweden
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Nottingham, United Kingdom
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Histologically/cytologically confirmed adenocarcinoma of the prostate
- Patient has received or is receiving hormonal treatment (orchiectomy, polyoestradiol phosphate, or gonadotropin-releasing hormone analogue with or without antiandrogen)
- Metastatic disease with positive bone scan within 2 months before treatment with more than one cancer related lesion or with one painful cancer related lesion in the presence of increasing PSA levels as follows: PSA >5 ng/ml, with increases on at least 2 successive occasions at least 2 weeks apart.
- Patient is referred to local field radiotherapy (EBR) for metastatic bone pain. The area to be treated (index site) should match the positive bone scan, local radiation area not exceeding 400 cm2
- ECOG performance status: 0-2
- Life expectancy: at least 3 months
- Age more than 40 years
Laboratory requirements:
- Hematology: Neutrophil count ≥1,5 x 109/L Platelet count at least ≥100 x109/L and stable Hemoglobin >100 g/l or 10 g/dL
- Hepatic function: Bilirubin within normal institutional limits ASAT and ALAT <2,5 times upper limit of normal (ULN)
- Renal function: Creatinine <1,5 times the ULN (i.e. NCI grade ≤1)
- Patient is willing and able to comply with the protocol, and agrees to return to the hospital for follow-up visits and examinations
- Patient has been fully informed about the study and has signed the informed consent form
Exclusion Criteria:
- Has received an investigational drug in the 4 weeks before or is scheduled to receiving one during the planned treatment period
- Has received chemo-, immunotherapy or external radiotherapy within weeks before study drug administration
- Has started treatment with bisphosphonates within 3 months before administration of study drug.
- Has previously received systemic radiotherapy with strontium, samarium or rhenium
- Change in hormonal therapy within the last 6 weeks before study drug administration
- Other currently active (relapse within the last 3 year) malignancy (except nonmelanoma skin cancer) or known brain, liver, lung, visceral and lymphatic metastases dominating the clinical picture of the patient
- Has received blood transfusion within last month
Other serious illness or medical condition as follows:
- any uncontrolled infection
- heart insufficiency, grade 3 or 4 as specified in NCI-CTC criteria
- grade 2 or greater motor or sensory neuropathy
- Crohn's disease or Ulcerative colitis 9) Known non-pathological bone fracture within the last two months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Radium-223 dichloride (Xofigo, BAY88-8223)
Each subject receives local filed external beam radiotherapy (EBR) and repeated injections of the investigational drug radium-223 (EBR+Radium-223)
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Four Radium-223 injections were given at 4-weekly intervals starting after the first fraction of EBR.
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PLACEBO_COMPARATOR: Saline
Each subject receives local filed external beam radiotherapy (EBR) and repeated injections of saline (EBR+placebo)
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Four Saline injections were given at 4-weekly intervals starting after the first fraction of EBR.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to occurrence of Skeletal-related Events (SRE)
Time Frame: Up to 12 Month
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SREs are defined as: Increase in pain severity index during the last week; Increase in analgesic consumption; Neurological symptoms secondary to skeletal manifestations of prostate cancer; New pathologic bone fractures (vertebral and non-vertebral); Tumour related orthopaedic surgical intervention; Subsequent external beam radiation to relieve skeletal pain; Use of radioisotopes to relieve new skeletal related symptoms; Use of corticosteroids for skeletal pain, at doses aimed for pain palliation; Use of chemotherapy, bisphosphonates, or hormones, for the treatment of skeletal disease progression
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Up to 12 Month
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Relative change (%) in bone-ALP levels from baseline to 4 weeks after last injection
Time Frame: Up to 12 Month
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Up to 12 Month
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Number of SREs per patient
Time Frame: Up to 12 Month
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Up to 12 Month
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Changes in the levels of biochemical markers of bone formation
Time Frame: Up to 12 Month
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Up to 12 Month
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Change in Prostate Specific Antigen (PSA)
Time Frame: Up to 12 Month
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Up to 12 Month
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Change in pain level
Time Frame: Up to 12 Month
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Up to 12 Month
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Changes in analgesic use during study period
Time Frame: Up to 12 Month
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Up to 12 Month
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Changes in Edmonton Symptom Assessment Scale (ESAS) from baseline
Time Frame: Up to 12 Month
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Up to 12 Month
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Overall survival
Time Frame: up to 24 months
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up to 24 months
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Adverse events
Time Frame: up to 24 months
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up to 24 months
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Clinical laboratory tests including haematology, renal and liver function parameters
Time Frame: up to 24 months
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up to 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (ACTUAL)
May 1, 2006
Study Completion (ACTUAL)
May 1, 2007
Study Registration Dates
First Submitted
April 11, 2007
First Submitted That Met QC Criteria
April 11, 2007
First Posted (ESTIMATE)
April 12, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
June 25, 2014
Last Update Submitted That Met QC Criteria
June 24, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15280
- BC1-02 (OTHER: Algeta ASA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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