Bony Metastases From Castrate Refractory Prostate Cancer
Conditions
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.
Interventions
Previously known as Alpharadin, Radium-223 dichloride is a calcium-mimetic, alpha emitting radiopharmaceutical, which introduces double-stranded DNA breaks in metastatic cancer cells.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prostate cancer patients scheduled for treatment with Radium-223.
Exclusion criteria
* Patients not completing their treatment regimen for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| (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 |
| (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. |
| 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. |
| 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 |
Countries
United States
Outcome results
None listed