A Phase III Study of Alpharadin (Radium-223)in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases - NCT00699751-70112 (Clinical Trial 374462)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy374462.aspx
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| City: |
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New Orleans |
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State:
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LA |
| Zip Code: |
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70112 |
| Conditions: |
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Hormone Refractory Prostate Cancer - Bone Metastases |
| Purpose: |
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Alsympca is an international Phase III clinical study to evaluate the efficacy and safety of
Alpharadin, in patients with hormone refractory prostate cancer and skeletal metastases.
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| Study summary: |
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The aim of the study is to compare, in patients with symptomatic HRPC and skeletal
metastases, the efficacy of best standard of care plus Alpharadin 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 (Alpharadin:Placebo). The study
treatment consists of 6 intravenous administrations of Alpharadin or placebo (saline) each
separated by an interval of 4 weeks. The patient will be followed until 3 years after first
study drug administration. |
| Criteria: |
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Main 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 for bone pain
Main 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 |
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| Study is available at: |
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Tulane University Hospital
New Orleans, LA 70112
United States
Primary Contact:
Bjørg Bolstad
Email: bjorg.bolstad@algeta.com
Phone: +47 23 00 79 90 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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