The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
NCT Number: NCT03368989
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.
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Notify Me18 year and older
Male
Observational
Houston, Texas, 77030, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Previously known as Alpharadin, Radium-223 dichloride is a calcium-mimetic, alpha emitting radiopharmaceutical, which introduces double-stranded DNA breaks in metastatic cancer cells.
Other names: Xofigo
Time frame: Pretreatment (about 30 days before treatment) and post treatment (about 4 weeks after treatment)
number of lesions specified before and after the treatment with a bone scan
Time frame: Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments
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
Time frame: Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments
As assessed using numeric rating score from 1-10 with 10 being the highest level of pain
Time frame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
normal level should be 4.0 ng/mL. value is measured after each dose
Time frame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
The normal value for alkaline phosphatase is 53 to 128 U/L.
Time frame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
The normal level for males is 14 to 18 g/dl
Time frame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
A normal platelet count ranges from 150,000 to 450,000 platelets
Time frame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
The normal range for neutrophils is 2.5-7.5 x 10 9 /L
Time frame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
Normal levels of creatinine in the blood are approximately 0.6 to 1.2 milligrams (mg) per deciliter (dL)
Time frame: pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments
The typical white blood cell count varies from 4,000 to 10,000 cells per mm3.
The University of Texas Health Science Center, Houston
Other
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