Trial Condition(s):

Prostatic Neoplasms

Radium-223 dichloride Asian population study in the treatment of CRPC patients with bone metastasis

Bayer Identifier:

15397

ClinicalTrials.gov Identifier:

NCT01810770

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the prostate
 - Patients diagnosed with progressive bone predominant metastatic Castration-Resistant Prostate Cancer (CRPC) /Hormone Refractory Prostate Cancer (HRPC) with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed) 
 - Known hormone refractory disease
 - No intention to use cytotoxic chemotherapy within the next 6 months
 - Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with external bean radiation therapy (EBRT) for bone pain within previous 12 weeks
 - Age >/= 18 years
 - Race is Asian
 - Eastern Co-operative Oncology Group (ECOG) Performance Status (PS): 0-2
 - Life expectancy >/= 6 months
 - Adequate bone marrow, liver and renal function as assessed by the Laboratory required by protocol
Exclusion Criteria
- Treatment with an investigational drug within previous 4 weeks prior to screening, or planned during the treatment or follow-up periods
 - Eligible for docetaxel treatment, i.e. subjects who are fit enough, willing and who are located where treatment with docetaxel is available
 - Treatment with cytotoxic chemotherapy within previous 4 weeks prior to screening, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks prior to screening (however ongoing neuropathy is permitted)
 - Prior hemibody external radiotherapy is excluded.  Subjects who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets.
 - Received systemic therapy radionuclides (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188, or radium-223 dichloride) for the treatment of bony metastases 
 - Blood transfusion or erythropoetin stimulating agents within the previous 4 weeks prior to screening
 - Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
 - Visceral metastases as assessed by abdominal/pelvic computed tomography (CT) or other imaging modality 
 - Presence of brain metastases
 - Lymphadenopathy exceeding 3 cm in short-axis diameter
 - Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis
 - Imminent or established spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Subjects with history of spinal cord compression should have completely recovered.
 - Received local practice implant therapy containing lodine-125 or Palladium-103 for the primary lesion of prostate cancer within the 6 months prior to screening.
 - Any other serious illness or medical condition

Trial Summary

Enrollment Goal
243
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Singapore, Singapore, 169610

Status
Completed
 
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Investigative Site

Singapore, Singapore, 258499

Status
Completed
 
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Investigative Site

Singapore, Singapore, 119228

Status
Completed
 
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Investigative Site

Singapore, Singapore

Status
Completed
 
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Investigative Site

Taipei, Taiwan, China, 10002

Status
Completed
 
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Investigative Site

Taoyuan, Taiwan, China, 333

Status
Completed
 
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Investigative Site

Taipei City, Taiwan, China, 112

Status
Completed
 
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Investigative Site

Kaohsiung, Taiwan, China, 81362

Status
Completed
 
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Investigative Site

Seoul, South Korea, 05505

Status
Completed
 
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Investigative Site

Seoul, South Korea, 03080

Status
Completed
 
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Investigative Site

Donggu,, South Korea, 61469

Status
Completed
 
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Investigative Site

Seoul, South Korea, 06351

Status
Completed
 
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Investigative Site

Shanghai, China, 200433

Status
Completed
 
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Investigative Site

Beijing, China, 100730

Status
Completed
 
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Investigative Site

Shanghai, China, 200032

Status
Completed
 
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Guangzhou, China

Status
Completed
 
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Investigative Site

Shanghai, China, 200127

Status
Completed
 
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Investigative Site

Shanghai, China, 200072

Status
Completed
 
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Investigative Site

Beijing, China, 100029

Status
Completed
 
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Investigative Site

Guangzhou, China, 510060

Status
Completed
 
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Investigative Site

Beijing, China, 100021

Status
Completed
 
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Investigative Site

Nanjing, China, 210008

Status
Completed
 
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Investigative Site

Nanjing, China, 210009

Status
Completed
 
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Investigative Site

Beijing, China, 100050

Status
Completed
 
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Investigative Site

Shanghai, China, 200040

Status
Completed
 
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Investigative Site

Beijing, China, 100020

Status
Completed
 
Locations

Investigative Site

Guangzhou, China, 510080

Status
Completed
 

Trial Design