Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )
Study Details
Study Description
Brief Summary
Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Xofigo (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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Most common treatment sequences [Up to 9 months]
Description of what treatments are given to treat mCRPC in first, second, third, and fourth line.
- 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
- Radiological progression free survival (rPFS) [Up to 9 months]
change in laboratory values from baseline for radiological progression free survival (rPFS)
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients were diagnosed with bone metastatic castration-resistant prostate cancer (mCRPC) per medical chart.
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Patients were at least 18 years of age as of the first diagnosis for mCRPC.
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Patients must have received at least one intravenous injection of Radium-223 (Xofigo).
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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:
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Patients who received Radium-223 as part in an interventional clinical trial
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Whippany | Whippany | New Jersey | United States | 07981 |
Sponsors and Collaborators
- Bayer
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 18919