Status:
COMPLETED
A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases
Lead Sponsor:
Bayer
Conditions:
Hormone Refractory Prostate Cancer
Bone Metastases
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prost...
Detailed Description
The aim of the study was to compare, in patients with symptomatic hormone refractory prostate cancer (HRPC) and skeletal metastases, the efficacy of best standard of care plus Radium-223 dichloride ve...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
921 Patients enrolled
Trial Details
Trial ID
NCT00699751
Start Date
June 1 2008
End Date
February 1 2014
Last Update
May 27 2016
Active Locations (134)
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1
Los Angeles, California, United States, 90048-0750
2
Roseville, California, United States, 95661
3
Tampa, Florida, United States, 33612
4
New Orleans, Louisiana, United States, 70112