Radium-223 Dichloride Asian Population Study in the Treatment of CRPC Patients With Bone Metastasis

Phase 3

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

• Registration Number: NCT01810770
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-12
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-14
• Study Start: 2013-03-26
• Primary Completion: 2017-09-25
• Study Completion: 2017-09-25
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-18
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 243

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radium-223 dichloride	Radium-223 dichloride (Xofigo, BAY88-8223)	-

Primary Outcome Measures

Name	Time	Method
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)	Up to 36 months	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.

Secondary Outcome Measures

Name	Time	Method
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	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)	Up to 36 months	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.
Time to pain progression	Up to 36 months