Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radium-223 dichloride | Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC), at least 18 years of age, must have received at least one intravenous injection of Radium-223. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xofigo (Radium-223 dichloride, BAY88-8223) | Drug | Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Most common treatment sequences | Description of what treatments are given to treat mCRPC in first, second, third, and fourth line. | Up to 9 months |
| Integration of Xofigo into the common treatment sequences, monotherapy or in combination. |
Not provided
Inclusion Criteria:
Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC) per medical chart.
Patients were at least 18 years of age as of the first diagnosis for mCRPC.
Patients must have received at least one intravenous injection of Radium-223 (Xofigo).
First injection of Radium-223 must have started between periods
1-January-2014 to 30-June-2014 or 15-November-2014 to present.
Patients must have a minimum of 12 months documented follow-up records following last Radium-223 treatment or death within 12 months of last dose.
Exclusion Criteria:
Not provided
Not provided
Not provided
mCRPC patients treated with Xofigo from 10 centers in the US
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Whippany | Whippany | New Jersey | 07981 | United States |
Not provided
| ID | Term |
|---|---|
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C581106 | radium Ra 223 dichloride |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Describe where is Xofigo given in the treatment paradigm, whether is given in combination with hormonals or chemotherapy or given as a monotherapy
| Up to 9 months |
| Mean Xofigo dose | Mean dose of each treatment received in the respective sequence | Up to 9 months |
| Duration of Xofigo treatment | Mean number of treatment cycles | Up to 9 months |
| Overall survival (OS) | Collect outcomes for patients following treatment for mCRPC including changes in overall survival | Up to 9 months |
| Time to radiographic progression | Collect outcomes for patients following treatment for mCRPC including changes in time to radiographic progression | Up to 9 months |
| Time to PSA (Prostate specific antigen) progression | Collect outcomes for patients following treatment for mCRPC including changes in PSA progression | Up to 9 months |
| Most common SRE (Skeletal Related Event) | The SRE occurring in the highest number of participants will be described. | Up to 9 months |
| Most common clinical intervention | Most common clinical intervention to treat SRE/SSEs such as radiation or bone surgery. | Up to 9 months |
| Time to first SSE(Symptomatic Skeletal Events) | Time to first SSE outcome will be analysed using the Kaplan Meier method | 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. | Up to 9 months |
| Change in laboratory values from baseline | for hemoglobin, platelets, neutrophils | Up to 9 months |
| Radiological progression free survival (rPFS) | change in laboratory values from baseline for radiological progression free survival (rPFS) | Up to 9 months |
| Time to alkaline phosphatase (ALP) progression | change in laboratory values from baseline for ALP | Up to 9 months |
| Time to visceral metastasis | time from baseline to the appearance of visceral metastasis | Up to 9 months |
| Time to onset of first subsequent treatment | or start of any other treatment for mCRPC | Up to 9 months |
| Pain | Based on chart reported pain | 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 | Up to 9 months |
| Type of physician | Define type of physicians that treat of mCRPC | 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 | 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 | 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 | 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 | Baseline and 12 weeks,Baseline and through study completion, an average of 1 year |
| D009369 |
| Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |