Bony Metastases From Castrate Refractory Prostate Cancer Clinical Trial
Official title:
The Effects of Radium-223 Dichloride Therapy on Radionuclide Bone Scan Lesions.
| Verified date | June 2019 |
| Source | The University of Texas Health Science Center, Houston |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | February 7, 2017 |
| Est. primary completion date | February 7, 2017 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Prostate cancer patients scheduled for treatment with Radium-223. Exclusion Criteria: - Patients not completing their treatment regimen for any reason |
| Country | Name | City | State |
|---|---|---|---|
| United States | The University of Texas Health Science Center at Houston | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Texas Health Science Center, Houston |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | (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 | |
| Secondary | (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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |