Status:
COMPLETED
Radium-223 Dichloride Asian Population Study in the Treatment of CRPC Patients With Bone Metastasis
Lead Sponsor:
Bayer
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 26 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2017
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT01810770
Start Date
March 26 2013
End Date
September 25 2017
Last Update
September 19 2018
Active Locations (27)
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1
Guangzhou, Guangdong, China, 510060
2
Guangzhou, Guangdong, China, 510080
3
Nanjing, Jiangsu, China, 210008
4
Nanjing, Jiangsu, China, 210009