Studienregister

Studienregister der Deutschen Gesellschaft für Urologie e.V.

ALSYMPCA

AcronymISRCTNEudraCTClinicaltrials.govDRKS
BC1-062007-006195-11

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

Algeta ASA, Oslo, Norwegen

Sponsor representative

Susanne Hegner

National Coordinating Investigator

Dr. med. Steffen Alexander Wedel

Monitoring

CRO-Pharmanet Services

Susanne Hegner

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