Hormone refractory prostate cancer and skeletal metastases Classification code 10060862
Conditions
Interventions
Product Name: Alpharadin
Product Code: Radium-223
Pharmaceutical Form: Injection*
Sponsors
Algeta ASA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed adenocarcinoma of the prostate. 2. Hormone refractory with evidence of rising PSA. 3. Multifocal skeletal metastases confirmed by bone scintigraphy within the last 8 weeks 4. Performance status: ECOG 0-2 5. Life expectancy: At least 6 months 6. Laboratory test results within required parameters. 7. The patient is willing and able to comply with the protocol (including maintenance of patient diary), and agrees to return to the hospital for follow-up visits and examination 8. The patient has been fully informed about the study and has 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
Exclusion criteria: 1. Has received an investigational drug within 4 weeks prior to the administration of radium-223, or is scheduled to receive one during the treatment and post-treatment period 2. Has received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to administration of study drug, or has not recovered from adverse events due to agents administered more than 4 weeks earlier 3. More than one regimen of previous cytotoxic chemotherapy 4. Has received prior hemibody external radiotherapy 5. Has a need for immediate external radiotherapy 6. 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 administration of study drug 7. Has started treatment with bisphosphonates less than 3 months prior to administration of study drug. Patients are allowed to be on bisphosphonates provided patient is on a stable dose for > 12 weeks before administration of study drug. 8. Patients who are <= 4 weeks (6 weeks for bicalutamide) post withdrawal of antiandrogen therapy 9. Patients who have started on systemic steroids, within a week prior to study drug administration or who have stopped steroids within a week prior to study drug administration 10. Other currently active (relapse within the last 3 years) malignancy (except non-melanoma skin cancer) that are not prostate cancer metastases 11. Visceral metastases from prostate cancer as assessed by abdominal/pelvic CT or MRI within six weeks before administration of study drug; Lung lesions from prostate cancer as assessed by Chest Xray within 6 weeks. This requirement does not include abdominal or pelvic lymph node involvement (individual lymph node size must not exceed 1 cm in short diameter) which is acceptable. 12. Bulky loco-regional disease 13. Other serious illness or medical condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the proportion of patients with PSA response (PSA decrease of 50% from baseline, confirmed three weeks later) of three different repeat dose regimens of Alpharadin in patients with hormone refractory prostate cancer and skeletal metastases, in order to select a dose for the Phase III programme. ; Secondary Objective: i) To compare the maximum percent decrease of PSA from baseline of three different repeat dose regimens of Alpharadin in order to select a dose for the Phase III programme. ii) To compare the effect on bone specific alkaline phosphatase (B-ALP) of three doses regimens of Alpharadin. iii) To examine for correlation between B-ALP and PSA. iv) To determine the effect of three different repeat dose regimens of Alpharadin on time to skeletal related events. v) To determine the effects of these three repeat dose regimens of Alpharadin on pain response, in patients with pain. vi) To determine the safety, tolerability and long-term toxicity of these three repeat dose regimens. vii) Time to death ;Primary end point(s): Prostate Specific Antigen (PSA) response; each patient will be classified as PSA responder/non-responder according to the definition of PSA response | — |
Countries
Czech Republic, Spain, United Kingdom
Outcome results
None listed