A double-blind, randomised, multiple dose, Phase III, multicentre study of Alpharadin in the treatment of patients with symptomatic hormone refractory prostate cancer with skeletal metastases. - Not Applicable

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 921

Inclusion Criteria

1. Histologically or cytologically confirmed adenocarcinoma of the prostate
2. Known hormone refractory disease defined as:
• Castrate serum testosterone level: = 50 ng/dL (1.7 nmol/L)
• Bilateral orchiectomy or maintenance on androgen ablation therapy with LHRH agonist or polyestradiol phosphate throughout the study
• Serum PSA progression defined as two consecutive increases in PSA over a previous reference value, each measurement at least 1 week apart
3. Serum PSA value = 5 ng/mL (µg/L)
4. Multiple skeletal metastases (= 2 hot spots) on bone scintigraphy within previous 12 weeks
5. No intention to use cytotoxic chemotherapy within the next 6 months
6. Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT for bone pain within previous 12 weeks
7. Age = 18 years
8. ECOG Performance status (PS): 0-2
9. Life expectancy = 6 months
10. Laboratory requirements:
a. Absolute neutrophil count (ANC) = 1.5 x 10^9/L
b. Platelet count = 100 x10^9/L
c. Hemoglobin = 10.0 g/dL (100 g/L; 6.2 mmol/L)
d. Total bilirubin level = 1.5 institutional upper limit of normal (ULN)
e. ASAT and ALAT = 2.5 ULN
f. Creatinine = 1.5 ULN
g. Albumin > 25 g/L
11. Willing and able to comply with the protocol, including follow-up visits and examinations
12. Must be fully informed about the study and signed the informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period
2. Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available
3. 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 (however ongoing neuropathy is permitted)
4. Prior hemibody external radiotherapy
5. Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks
6. Prior treatment with radium-223
7. Blood transfusion or erythropoetin stimulating agents within previous 4 weeks
8. Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
9. History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks
10. Malignant lymphadenopathy exceeding 3 cm in short-axis diameter
11. Imminent or established spinal cord compression based on clinical findings and/or MRI
12. Any other serious illness or medical condition such as, but not limited to:
• any uncontrolled infection
• cardiac failure NYHA III or IV
• Crohns disease or Ulcerative colitis
• Bone marrow dysplasia
13. Unmanageable faecal incontinence

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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