Japanese BAY88-8223 Monotherapy Phase II Study

Study Overview
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Brief Summary
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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

Official Title
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A Single-arm, Open-label, Multicenter, Phase II Study of BAY88-8223 in the Treatment of Japanese Patients With Symptomatic Castration-resistant Prostate Cancer (CRPC) With Bone Metastases

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: Radium-223 dichloride (Xofigo, BAY88-8223)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radium-223 dichloride<br> | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)<br>* BAY88-8223, 50 kBq/kg will be administered as slow bolus intravenous injection 6 times at intervals of 4 weeks between each administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of change in total alkaline phosphatase from baseline at 12 weeks |  | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of change in total alkaline phosphatase at the end of treatment |  | Baseline and 24 weeks | 
| 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 | 
| Time to prostate specific antigen progression |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase II, symptomatic castration-resistant prostate cancer, bone metastases