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To evaluate the safety and efficacy (Overall survival [OS]) of multiple doses of Ra-223 dichloride in an Asian population of subjects with CRPC metastatic to the bone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radium-223 dichloride | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radium-223 dichloride (Xofigo, BAY88-8223) | Drug | Radium-223 dichloride, 55 kBq/kg body weight, will be administered as a slow bolus IV injection at 4 week intervals for up to 6 doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | Up to 36 months | |
| Number of participants with laboratory changes | Up to 36 months | |
| Number of participants with changes in vital signs | Up to 36 months | |
| Number of participants with changes in electrocardiogram (ECG) | Up to 36 months | |
| Overall Survival (OS) | OS is defined as the time from date of first study drug treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact. | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in total Alkaline Phosphate (ALP) in serum | Up to 36 months | |
| Number of participants with total-ALP normalization | Up to 36 months | |
| Time to total ALP progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou | Guangdong | 510060 | China | |||
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| Up to 36 months |
| Changes in prostate specific antigen (PSA) in serum | Up to 36 months |
| Time to PSA progression | Up to 36 months |
| Time to first skeletal related event (SRE) | Up to 36 months |
| SRE free survival | Up to 36 months |
| Time to occurrence of first use of radio-isotopes to relieve skeletal symptoms | Up to 36 months |
| Time to occurrence of first start of any other anti-cancer treatment | Up to 36 months |
| Time to occurrence of first deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | Up to 36 months |
| Quality of life (QoL) | QoL is assessed by the scores got from the Functional Assessment of Cancer Therapy in subjects with prostate cancer (FACT-P) questionnaire, EuroQoL (EQ-5D) questionnaire, and the BPI-SF questionnaire. | Up to 36 months |
| Time to pain progression | Up to 36 months |
| Guangzhou |
| Guangdong |
| 510080 |
| China |
| Nanjing | Jiangsu | 210008 | China |
| Nanjing | Jiangsu | 210009 | China |
| Beijing | 100020 | China |
| Beijing | 100021 | China |
| Beijing | 100029 | China |
| Beijing | 100050 | China |
| Beijing | 100730 | China |
| Guangzhou | China |
| Shanghai | 200032 | China |
| Shanghai | 200040 | China |
| Shanghai | 200072 | China |
| Shanghai | 200127 | China |
| Shanghai | 200433 | China |
| Singapore | 119228 | Singapore |
| Singapore | 169610 | Singapore |
| Singapore | 258499 | Singapore |
| Singapore | Singapore |
| Donggu | Gwangju Gwang''yeogsi | 61469 | South Korea |
| Seoul | 03080 | South Korea |
| Seoul | 05505 | South Korea |
| Seoul | 06351 | South Korea |
| Taipei City | Taipei | 112 | Taiwan |
| Kaohsiung City | 81362 | Taiwan |
| Taipei | 10002 | Taiwan |
| Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C581106 | radium Ra 223 dichloride |
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