Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC.
This is a chart review of 200 Xofigo patients to describe sequencing and characterize clinical parameters and patient determinants that drive physician decision making.
Study Type
OBSERVATIONAL
Enrollment
200
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.
Whippany
Whippany, New Jersey, United States
Determining factors that drive physician decision for treatment selection.
The treating physician should select out of the following options: Prostate Specific Antigen rising, Alkaline phosphatase (ALP) , Lactate dehydrogenase (LHD), testosterone, pain, symptoms, bone lesions, disease progression.
Time frame: Up to 9 months
Most common treatment sequences
Description of what treatments are given to treat mCRPC in first, second, third, and fourth line.
Time frame: Up to 9 months
Integration of Xofigo into the common treatment sequences, monotherapy or in combination.
Describe where is Xofigo given in the treatment paradigm, whether is given in combination with hormonals or chemotherapy or given as a monotherapy
Time frame: Up to 9 months
Mean Xofigo dose
Mean dose of each treatment received in the respective sequence
Time frame: Up to 9 months
Duration of Xofigo treatment
Mean number of treatment cycles
Time frame: Up to 9 months
Overall survival (OS)
Collect outcomes for patients following treatment for mCRPC including changes in overall survival
Time frame: Up to 9 months
Time to radiographic progression
Collect outcomes for patients following treatment for mCRPC including changes in time to radiographic progression
Time frame: Up to 9 months
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Time to PSA (Prostate specific antigen) progression
Collect outcomes for patients following treatment for mCRPC including changes in PSA progression
Time frame: Up to 9 months
Most common SRE (Skeletal Related Event)
The SRE occurring in the highest number of participants will be described.
Time frame: Up to 9 months
Most common clinical intervention
Most common clinical intervention to treat SRE/SSEs such as radiation or bone surgery.
Time frame: Up to 9 months
Time to first SSE(Symptomatic Skeletal Events)
Time to first SSE outcome will be analysed using the Kaplan Meier method
Time frame: Up to 9 months
Reasons for discontinuation
The treating physician should select out of the following options: Prostate Specific Antigen rising, Alkaline phosphatase (ALP) , Lactate dehydrogenase (LHD)), testosterone, pain, symptoms, bone lesions, disease progression.
Time frame: Up to 9 months
Change in laboratory values from baseline
for hemoglobin, platelets, neutrophils
Time frame: Up to 9 months
Radiological progression free survival (rPFS)
change in laboratory values from baseline for radiological progression free survival (rPFS)
Time frame: Up to 9 months
Time to alkaline phosphatase (ALP) progression
change in laboratory values from baseline for ALP
Time frame: Up to 9 months
Time to visceral metastasis
time from baseline to the appearance of visceral metastasis
Time frame: Up to 9 months
Time to onset of first subsequent treatment
or start of any other treatment for mCRPC
Time frame: Up to 9 months
Pain
Based on chart reported pain
Time frame: Up to 9 months
Most common symptoms
The participant and the treating physician should select out of the following list: fatigue, hypertension, cognitive disorder, seizures, edema, hypokalemia, cardiac disorders, hepatotoxicity, anemia, neutropenia, febrile neutropenia, thrombocytopenia
Time frame: Up to 9 months
Type of physician
Define type of physicians that treat of mCRPC
Time frame: Up to 9 months
Change in PSA from baseline to 12 weeks, and baseline to discontinuation
Measure PSA closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation
Time frame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
Resource utilization
Number of outpatient, inpatient and emergency room visits as well as number of hospitalizations
Time frame: Up to 9 months
Change in ALP from baseline to 12 weeks, and baseline to discontinuation
Measure ALP closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation
Time frame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
Change in LDH from baseline to 12 weeks, and baseline to discontinuation
Measure LDH values closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation
Time frame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year