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

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: Male

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 prostate cancer and skeletal metastases.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Hormones; Radium Ra 223 dichloride; Succinylcholine

Criteria

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 (External Beam Radiation Therapy) for bone pain

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