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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hormone Refractory Prostate Cancer, Bone Metastases

In brief

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.

Key facts

Study ID

NCT00699751

Run by

Bayer

People needed

921

Starts

2008-06-12

Expected to finish

2014-02-13

Last updated by the study team

2026-02-23

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Roseville, California, United States
• Study site — Tampa, Florida, United States
• Study site — New Orleans, Louisiana, United States
• Study site — St Louis, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Liverpool, New South Wales, Australia
• Study site — Randwick, New South Wales, Australia
• Study site — St Leonards, New South Wales, Australia
• Study site — Sydney, New South Wales, Australia
• Study site — Wahroonga, New South Wales, Australia
• Study site — Wollongong, New South Wales, Australia
• Study site — Herston, Queensland, Australia
• Study site — Toowoomba, Queensland, Australia
• Study site — Adelaide, South Australia, Australia
• Study site — Woodville South, South Australia, Australia
• Study site — Hobart, Tasmania, Australia
• Study site — Fitzroy, Victoria, Australia
• Study site — Nedlands, Western Australia, Australia
• Study site — Kortrijk, Belgium
• Study site — Ottignies, Belgium
• Study site — Salvador, Estado de Bahia, Brazil
• Study site — Belo Horizonte, Minas Gerais, Brazil
• Study site — Rio de Janeiro, Rio de Janeiro, Brazil
• Study site — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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