Prostatic Neoplasms, Castration-Resistant
Conditions
Brief summary
Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC.
Detailed description
This is a chart review of 200 Xofigo patients to describe sequencing and characterize clinical parameters and patient determinants that drive physician decision making.
Interventions
DRUGXofigo (Radium-223 dichloride, BAY88-8223)
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.
Sponsors
Bayer
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
* Patients who received Radium-223 as part in an interventional clinical trial * Actively treated, or expect to be treated, in 6 months before last follow-up, for any other malignancy with the exception of non-metastatic skin cancer or low-grade superficial bladder cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determining factors that drive physician decision for treatment selection. | Up to 9 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Integration of Xofigo into the common treatment sequences, monotherapy or in combination. | Up to 9 months | Describe where is Xofigo given in the treatment paradigm, whether is given in combination with hormonals or chemotherapy or given as a monotherapy |
| Mean Xofigo dose | Up to 9 months | Mean dose of each treatment received in the respective sequence |
| Duration of Xofigo treatment | Up to 9 months | Mean number of treatment cycles |
| Overall survival (OS) | Up to 9 months | Collect outcomes for patients following treatment for mCRPC including changes in overall survival |
| Time to radiographic progression | Up to 9 months | Collect outcomes for patients following treatment for mCRPC including changes in time to radiographic progression |
| Time to PSA (Prostate specific antigen) progression | Up to 9 months | Collect outcomes for patients following treatment for mCRPC including changes in PSA progression |
| Most common SRE (Skeletal Related Event) | Up to 9 months | The SRE occurring in the highest number of participants will be described. |
| Most common clinical intervention | Up to 9 months | Most common clinical intervention to treat SRE/SSEs such as radiation or bone surgery. |
| Time to first SSE(Symptomatic Skeletal Events) | Up to 9 months | Time to first SSE outcome will be analysed using the Kaplan Meier method |
| Reasons for discontinuation | Up to 9 months | 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. |
| Change in laboratory values from baseline | Up to 9 months | for hemoglobin, platelets, neutrophils |
| Most common treatment sequences | Up to 9 months | Description of what treatments are given to treat mCRPC in first, second, third, and fourth line. |
| Time to alkaline phosphatase (ALP) progression | Up to 9 months | change in laboratory values from baseline for ALP |
| Time to visceral metastasis | Up to 9 months | time from baseline to the appearance of visceral metastasis |
| Time to onset of first subsequent treatment | Up to 9 months | or start of any other treatment for mCRPC |
| Pain | Up to 9 months | Based on chart reported pain |
| Most common symptoms | Up to 9 months | 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 |
| Type of physician | Up to 9 months | Define type of physicians that treat of mCRPC |
| Change in PSA from baseline to 12 weeks, and baseline to discontinuation | Baseline and 12 weeks,Baseline and through study completion, an average of 1 year | Measure PSA closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation |
| Resource utilization | Up to 9 months | Number of outpatient, inpatient and emergency room visits as well as number of hospitalizations |
| Change in ALP from baseline to 12 weeks, and baseline to discontinuation | Baseline and 12 weeks,Baseline and through study completion, an average of 1 year | Measure ALP closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation |
| Change in LDH from baseline to 12 weeks, and baseline to discontinuation | Baseline and 12 weeks,Baseline and through study completion, an average of 1 year | Measure LDH values closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation |
| Radiological progression free survival (rPFS) | Up to 9 months | change in laboratory values from baseline for radiological progression free survival (rPFS) |
Countries
United States
Outcome results
None listed