Studienregister der Deutschen Gesellschaft für Urologie e.V.
ALSYMPCA
- Overall Trial
- Study Sites (1)
Acronym | ISRCTN | EudraCT | NCT (clinicaltrials.gov) | DRKS |
---|---|---|---|---|
BC1-06 | 2007-006195-11 |
A double-blind, randomised, multiple dose, phase III, multicentre study of AlpharadinTM in the treatment of patients with symptomatic hormone refractory prostate cancer with skeletal metastases
Status: Active
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
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)
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