Radium 223 in Castrate Resistant Prostate Cancer Bone Metastases
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02135484|
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : November 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Alpharadin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Observation, Open Label Study of Alpharadin (Radium 223) in Patients With Castrate Resistant Prostate Cancer Bone Metastases|
|Actual Study Start Date :||September 19, 2014|
|Actual Primary Completion Date :||November 11, 2020|
|Actual Study Completion Date :||November 11, 2020|
Participants treated with standard dosing of Alpharadin 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
- Biomarkers in Predicting Overall Survival [ Time Frame: 3 months ]Each marker tested individually using a Cox regression model to determine whether it is associated with overall survival. Overall survival (OS) measured as the number of months from enrollment until death. Markers measured on a continuous or ordinal scale included with their original units in the model. Baseline values used to determine if baseline is associated with survival. Percent change calculated from baseline and used as a continuous measure in the model. Ordered category of reduced by 30%, same, or increased by 30% grouping used in the model. All observed values of marker included as a time-varying covariate in the Cox regression model.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135484
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||John Araujo, MD,PHD||M.D. Anderson Cancer Center|