The Effects of Radium-223 Dichloride Therapy on Radionuclide Bone Scan Lesions.

Study Overview
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Brief Summary
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To describe the changes seen on bone scan and correlate them with changes in relative chemical biomarkers, patient's functional status and level of pain.

Official Title
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The Effects of Radium-223 Dichloride Therapy on Radionuclide Bone Scan Lesions.

Conditions
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Bony Metastases From Castrate Refractory Prostate Cancer

Intervention / Treatment
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* Drug: Radium-223 dichloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prostate cancer patients scheduled for treatment with Radium-223. Exclusion Criteria: Patients not completing their treatment regimen for any reason

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| treatment with radium-223 Dichloride (Xofigo)<br> | Drug: Radium-223 dichloride<br>* Previously known as Alpharadin, Radium-223 dichloride is a calcium-mimetic, alpha emitting radiopharmaceutical, which introduces double-stranded DNA breaks in metastatic cancer cells.<br>* Other names: Xofigo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of osteoblastic bone lesions | number of lesions specified before and after the treatment with a bone scan | Pretreatment (about 30 days before treatment) and post treatment (about 4 weeks after treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional status as indicated by score on the Eastern Cooperative Oncology Group (ECOG) performance scale | The ECOG scale describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). The possible scores on the scale are 0 to 5, with 0 being the best outcome and 5 being the worst outcome, details of each score are listed below. Grade 0 = Fully active, able to carry on all pre-disease performance without restriction Grade 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Grade 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours Grade 3 = Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours Grade 4 = Completely disabled; cannot carry on any selfcare; totally confined to bed or chair Grade 5 = Dead | Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments | 
| pain level as assessed by numeric rating score | As assessed using numeric rating score from 1-10 with 10 being the highest level of pain | Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments | 
| (PSA) prostate specific antigen level | normal level should be 4.0 ng/mL. value is measured after each dose | pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments | 
| (ALP) alkaline phosphatase level | The normal value for alkaline phosphatase is 53 to 128 U/L. | pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments | 
| Hemoglobin level | The normal level for males is 14 to 18 g/dl | pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments | 
| Platelet level | A normal platelet count ranges from 150,000 to 450,000 platelets | pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments | 
| Neutrophil count | The normal range for neutrophils is 2.5-7.5 x 10 9 /L | pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments | 
| Creatinine level | Normal levels of creatinine in the blood are approximately 0.6 to 1.2 milligrams (mg) per deciliter (dL) | pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments | 
| white blood cell count | The typical white blood cell count varies from 4,000 to 10,000 cells per mm3. | pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments |