The target population is patients suffering from bone pain due to skeletal metastasis secondary to prostate cancer.
Conditions
Interventions
Product Name: Alpharadin
Product Code: NA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA (The INN Expert group has confirmed not to assign an INN name for this well-established ch
Sponsors
Algeta AS
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Histologically/cytologically confirmed adenocarcinoma of the prostate 2. Patient is hormone refractory with evidence of progressive disease: - Patient must be maintained on androgen ablation therapy with LHRH agonist, or is currently treated with polyestradiolphosphate to castrate level, or have undergone orchiectomy - Patient’s testosterone level is required to be equal to or below 50 ng/dl - Patients in which flutamide, nilutamide, megestrol acetate, polyestradiolphosphate, aminoglutethimide, and ketoconazole, has been recently added or withdrawn must demonstrate progression of disease and be at least 4 weeks beyond the start or discontinuation of such agents; for bicalutamide 6 weeks is required - Increase in PSA levels in two consecutive measurements with at least one week apart, demonstrating an increase over the reference (nadir) value, and with the final PSA > 5 ng/ml o A reference PSA (nadir) value must be measured at least 4 weeks after the start or discontinuation of flutamide, nilutamide, megestrol acetate, polyestradiolphosphate, aminoglutethimide, and ketoconazole, and at least 6 weeks after start or discontinuation of bicalutamide o If the third PSA value is lower than the second value, the patient could still be eligible, provided a fourth measurement obtained at least 1 week after the third PSA value, is greater than the second PSA value and > 5 ng/ml 3. Multifocal (>1) skeletal metastases confirmed by bone scintigraphy within the last 6 weeks 4. Bone pain with a score of at least 2 on BPI average pain, despite adequate use of analgesics, that correlates with areas of increased uptake (osteoblastic activity) on bone scintigraphy 5. Performance status: ECOG 0-2 or Karnofsky ³ 60% 6. Life expectancy: At least 3 months 7. Age more than 40 years 8. Laboratory requirements: a. Neutrophil count > 1,5 x 109/L b. Platelet count at least > 100 x109/L c. Hemoglobin > 95 g/L d. Bilirubin within normal institutional limits e. ASAT and ALAT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Has received an investigational drug within 4 weeks before the administration of radium-223, or is scheduled to receiving one during the study period 2. Has received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier 3. Has received prior hemibody external radiotherapy 4. Has received systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last year prior to inclusion 5. Has started treatment with bisphosphonates less than 3 months prior to administration of study drug 6. Patients experiencing hormone withdrawal syndrome, or are < 4 weeks post withdrawal of antiandrogen therapy (6 weeks for bicalutamide) 7. Patients who have started steroids or changed to treatment with steroids within the last 4 weeks prior to administration of radium-223 8. Has other clinically significant or symptomatic disease, which might interfere with the assessment of bone pain, e.g. spinal cord compression, compression or infiltration of a neural plexus, nerve root or peripheral nerves 9. Other currently active (relapse within the last 3 year) malignancy (except non-melanoma skin cancer), or known brain or visceral metastases dominating the clinical picture of the patient 10. Other serious illness or medical condition: - any uncontrolled infection - cardiac failure Classification III or IV (New York Heart Association) - Crohn disease or Ulcerative colitis - known bone fracture within 8 weeks 11. Patients with imminent or established spinal cord compression based on clinical findings and/or MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether there is a dose-response relationship for radium-223 in patients with painful bone metastases secondary to prostate carcinoma regarding the palliation of bone pain. The palliative efficacy will be established through assessments of bone pain and consumption of analgesia. ;Secondary Objective: The secondary objective is to find the most efficient dose with an acceptable safety profile. The safety will be assessed through measurements of adverse events, and acute haematological toxicity during the study period. Long-term chronic toxicity, and the overall survival at one and two year post-treatment will also be assessed.;Primary end point(s): The primary endpoints are the endpoints needed to classify a patient as a pain responder (“minimal response”, “moderate response”, “marked response” or “complete response”) or a non-responder (“no pain response” or “pain progression”) (see paragraph 9.1.3). These endpoints are: - Pain assessment; the patient’s self assessment of his “average pain over the last 24 hours” using a 100 mm Visual Analogue Scale where 0 is “no pain” and 100 is “pain as bad as you can imagine” - Analgesic consumption The classification of each patient into one, and only one, of the categories will be based on a combination of the change of bone pain (reduction or increased compared to baseline), and change in analgesic consumption during the study period compared to the patient’s prescribed analgesic consumption at baseline. | — |
Countries
Sweden, United Kingdom
Outcome results
None listed