Purpose / Objectives

Primary Outcome

• The efficacy of Alpharadin: To compare, overall survival of patients in the treatment arm with best standard of care plus Alpharadin versus best standard of care plus placebo.

Secondary Outcomes

• Time to occurrence of specified disease events
• Changes PSA and total ALP
• The acute and long term safety profile

Diagnosis

• Malignant neoplasm of prostate

Patients with HRPC with at least 2 bone metastases, bone pain (or treatment against bone pain)

Patient attributes

Stage

HRPC, bone metastases

Age

18-120

Inclusion criteria

• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Known hormone refractory disease at least (under 1 or several hormone ablation regimen)
• Skeletal metastases (≥ 2 hot spots)
• No intention to use cytotoxic chemotherapy within the next 6 months
• Either regular (not occasional) analgesic medication or treatment with EBRT for bone pain within previous 12 weeks for cancer related bone pain
• ECOG Performance status: 0-2
• Life expectancy ≥ 6 months
• Absolute neutrophil count 1.5 x 10 ⁹/L
• Platelet count 100 x10 ⁹/L
• Hemoglobin 10.0 g/dL (100 g/L; 6.2 mmol/L)

Exclusion criteria

• Treatment with cytotoxic chemotherapy  planned during the treatment period
• Prior hemibody external radiotherapy
• Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks
• Prior treatment with radium-223
• Blood transfusion or erythropoetin stimulating agents within previous 4 weeks
• History of visceral metastasis
• Malignant lymphadenopathy exceeding 3 cm
• Spinal cord compression
• Unmanageable faecal incontinence

Trial design

• Phase III
• Multicenter
• Randomized
• Two-arm
• Double-blind
• Placebo-controlled

Intervention

• Treatment period consists of 6 intravenous administrations of Alpharadin (Radium-223-Chlorid) or placebo (normal saline) each separated by an interval of 4 weeks
• Verum / Placebo 2 : 1
• In addition patients should receive the best standard of care and may receive EBERT

Miscellaneous

• Phase II study resulted in an improved survival of 65 weeks in the verum group versus 46 Weeks in the Placebo group and
• Improved quality of live and pain reduction
• Radium 223 demonstrated a good safety profile and no dose dependent hematoxicity

Documents (password protected)

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Responsibilities in overall trial

Sponsor

Algeta ASA, Oslo, Norwegen

• Tel. +47 23 00 79 90
• Fax +47 23 00 79 91
• post@algeta.com

Sponsor representative

Susanne Hegner

• Tel. 06102813195
• Fax 06102813599
• shegner@pharmanet.com

National Coordinating Investigator

Dr. med. Steffen Alexander Wedel

Monitoring

CRO-Pharmanet Services

• Tel. 06102 813-195
• Fax 06102 813-599
• shegner@pharmanet.com

Susanne Hegner