Prostatic Neoplasms
Conditions
Keywords
Phase II, symptomatic castration-resistant prostate cancer, bone metastases
Brief summary
To evaluate the efficacy and safety of the best standard of care plus BAY88-8223 in Japanese patients with CRPC and bone metastases after a multiple administration
Interventions
DRUGRadium-223 dichloride (Xofigo, BAY88-8223)
BAY88-8223, 50 kBq/kg will be administered as slow bolus intravenous injection 6 times at intervals of 4 weeks between each administration
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have received docetaxel or not eligible for the first course of docetaxel, i.e. patients who are not fit enough and willing. * Histologically or cytologically confirmed adenocarcinoma of the prostate * Multiple bone metastases * Either regular (not occasional) analgesic medication use for cancer-related bone pain or treatment with external beam radiotherapy (EBRT) for bone pain. * Best standard of care(BSoC) is regarded as the routine standard of care.
Exclusion criteria
: * Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period * History of visceral metastasis, or presence of visceral metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of change in total alkaline phosphatase from baseline at 12 weeks | Baseline and 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percentages of change in bone ALP at 12 weeks | Baseline and 12 weeks |
| Percentages of change in bone ALP at the end of treatment | Baseline and 24 weeks |
| The proportion of subjects who have total alkaline phosphatase normalization at 12 weeks | 12 weeks |
| The proportion of subjects who have total alkaline phosphatase normalization at the end of treatment | 24 weeks |
| The proportion of subjects who have bone alkaline phosphatase normalization at 12 weeks | 12 weeks |
| The proportion of subjects who have bone alkaline phosphatase normalization at the end of treatment | 24 weeks |
| Percentage of change in total alkaline phosphatase at the end of treatment | Baseline and 24 weeks |
| Overall survival | 3 years |
| Percentages of change in biomarkers of bone turnover at each time point | Baseline and 36 weeks |
| Number of participants with drug related adverse events and serious adverse events as a measure of safety and tolerability | 3 years |
| Incidence of treatment-emergent adverse events (TEAEs) | 24 weeks plus 30 days |
| Number of participants with abnormal laboratory values | 36 weeks |
| Time to prostate specific antigen progression | 24 weeks |
Countries
Japan
Outcome results
None listed