The Effects of Radium-223 Dichloride Therapy on Radionuclide Bone Scan Lesions.
- Conditions
- Bony Metastases From Castrate Refractory Prostate Cancer
- Interventions
- Registration Number
- NCT03368989
- Lead Sponsor
- The University of Texas Health Science Center, Houston
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 21
- Prostate cancer patients scheduled for treatment with Radium-223.
- Patients not completing their treatment regimen for any reason
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description treatment with radium-223 Dichloride (Xofigo) Radium-223 dichloride -
- Primary Outcome Measures
Name Time Method Change in number of osteoblastic bone lesions 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
- Secondary Outcome Measures
Name Time Method Hemoglobin level 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
functional status as indicated by score on the Eastern Cooperative Oncology Group (ECOG) performance scale 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(ALP) alkaline phosphatase level 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.
pain level as assessed by numeric rating score 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
Platelet level 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
(PSA) prostate specific antigen level 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
Neutrophil count 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
Creatinine level 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)
white blood cell count 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.
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States