Clinical Trial · NCT00699751

A Phase III Study of Radium-223 Dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases

Overview

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 prostate cancer and skeletal metastases.

Sponsor

Bayer

Phase

Phase 3

Contacts

Christopher Parker, MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT00699751

Drug / Compound

dichloride

Isotope(s):

Target(s):

Bone Metabolism

Ligand Class: Small Molecules

Eligibility

Inclusion

Histologically or cytologically confirmed adenocarcinoma of the prostate
Known hormone refractory disease
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
Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy

Exclusion

Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available
Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period
History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks
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

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

Locations

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