Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )
- Conditions
- Prostatic Neoplasms, Castration-Resistant
- Interventions
- Registration Number
- NCT02899104
- Lead Sponsor
- Bayer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 200
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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.
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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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Radium-223 dichloride Xofigo (Radium-223 dichloride, BAY88-8223) 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (1)
Whippany
🇺🇸Whippany, New Jersey, United States