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A Phase III Study of Alpharadin (Radium-223)in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases - NCT00699751-70112(Clinical Trial 374462)



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City:  New Orleans
State:  
LA
Zip Code: 70112
Conditions: Hormone Refractory Prostate Cancer - Bone Metastases
Purpose: 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.
Study summary: 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: 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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Data Source: ClinicalTrials.gov
Date Processed: January 5, 2011
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