NCT03368989CompletedNot Applicable
The Effects of Radium-223 Dichloride Therapy on Radionuclide Bone Scan Lesions.
The University of Texas Health Science Center, Houston1 site in 1 country21 target enrollmentStarted: February 11, 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Change in number of osteoblastic bone lesions
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts 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
Arms & Interventions
treatment with radium-223 Dichloride (Xofigo)
Intervention: Radium-223 dichloride (Drug)
Outcomes
Primary Outcomes
Change in number of osteoblastic bone lesions
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
Secondary Outcomes
- Hemoglobin level(pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments)
- 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)
- (ALP) alkaline phosphatase level(pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments)
- pain level as assessed by numeric rating score(Pretreatment (about 1 to 3 days before each treatment) for a total of 6 treatments)
- Platelet level(pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments)
- (PSA) prostate specific antigen level(pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments)
- Neutrophil count(pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments)
- Creatinine level(pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments)
- white blood cell count(pretreatment (about 1 to 7 days before each treatment) for a total of 6 treatments)
Investigators
Isis W Gayed
Professor
The University of Texas Health Science Center, Houston
Study Sites (1)
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