A double blind, randomised, multiple dose, phase III, multicentre study of AlpharadinTM in the treatment of patients with hormone-refractory prostate cancer with skeletal metastases - ND

• Conditions: progressive symptomatic HRPC, with at least two skeletal metastases on bone scan and no known visceral metastases; MedDRA version: 9.1Level: LLTClassification code 10005993Term: Bone metastases

• Registration Number: EUCTR2007-006195-11-IT
• Lead Sponsor: ALGETA ASA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-24
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 750

Inclusion Criteria

1.Histologically or cytologically confirmed adenocarcinoma of the prostate 2. Known hormone refractory disease defined as: &#56256;&#56440; Castrate serum testosterone level:<= 50 ng/dL &#56256;&#56440; Bilateral orchiectomy or maintenance on androgen ablation therapy with LHRH agonist or polyestradiol phosphate throughout the study 3. Serum PSA progression defined as two consecutive increases in PSA over a previous reference value, each measurement at least 1 week apart) 4. Serum PSA value >= 5 ng/mL (&#956;g/L) 5. Multiple skeletal metastases (>= 2 hot spots) on bone scintigraphy within previous 12 weeks 6. No intention to use cytotoxic chemotherapy within the next 6 months 7. Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT for bone pain within previous 12 weeks 8. Age >=18 years 9. ECOG Performance status (PS): 0-2 10. Life expectancy >= 6 months 11. Laboratory requirements: a. Absolute neutrophil count (ANC) >= 1.5 x 109/L b. Platelet count >=100 x109/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 12. Willing and able to comply with the protocol, including follow-up visits and examinations 13. 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. 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 3. Prior hemibody external radiotherapy 4. Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks 5. Prior treatment with radium-223 6. Blood transfusion or erythropoetin stimulating agents within previous 4 weeks 7. Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer) 8. History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks 9. Malignant lymphadenopathy exceeding 3 cm in short-axis diameter 10. Imminent or established spinal cord compression based on clinical findings and/or MRI 11. Any other serious illness or medical condition such as, but not limited to: &#56256;&#56451; any uncontrolled infection &#56256;&#56451; cardiac failure NYHA III or IV &#56256;&#56451; Crohns disease or Ulcerative colitis &#56256;&#56451; Bone marrow dysplasia 12. Unmanageable faecal incontinence

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare, in patients with symptomatic HRPC and skeletal metastases, the efficacy of best standard of care plus Alpharadin versus best standard of care plus placebo, with the primary efficacy endpoint being overall survival (OS).;Secondary Objective: To compare, in patients with symptomatic HRPC and skeletal metastases receiving either best standard of care plus Alpharadin versus best standard of care plus placebo:1)Time to occurrence of specified disease events 2)Changes and time to progression in serum PSA and total ALP concentrations 3)The acute and long term safety profile 4) Quality of life 5) Health economics;Primary end point(s): Overall survival: time from date of randomisation to the date of death