Trial Condition(s):
Prostatic Neoplasms, Castration-Resistant
Navigant study- treatment patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer ) (Navigant)
Bayer Identifier:
18919
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC.
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.
Trial Summary
Enrollment Goal
200
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Whippany Whippany, United States, 07981 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Current Management, Treatment Patterns and Outcomes of Metastatic Castrate Resistant Prostate Cancer Patients treated with Radium-223
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- 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.Timeframe: Up to 9 months
Secondary Outcome
- Most common treatment sequencesDescription of what treatments are given to treat mCRPC in first, second, third, and fourth line.Timeframe: 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 monotherapyTimeframe: Up to 9 months
- Mean Xofigo doseMean dose of each treatment received in the respective sequenceTimeframe: Up to 9 months
- Duration of Xofigo treatmentMean number of treatment cyclesTimeframe: Up to 9 months
- Overall survival (OS)Collect outcomes for patients following treatment for mCRPC including changes in overall survivalTimeframe: Up to 9 months
- Time to radiographic progressionCollect outcomes for patients following treatment for mCRPC including changes in time to radiographic progressionTimeframe: Up to 9 months
- Time to PSA (Prostate specific antigen) progressionCollect outcomes for patients following treatment for mCRPC including changes in PSA progressionTimeframe: Up to 9 months
- Most common SRE (Skeletal Related Event)The SRE occurring in the highest number of participants will be described.Timeframe: Up to 9 months
- Most common clinical interventionMost common clinical intervention to treat SRE/SSEs such as radiation or bone surgery.Timeframe: Up to 9 months
- Time to first SSE(Symptomatic Skeletal Events)Time to first SSE outcome will be analysed using the Kaplan Meier methodTimeframe: Up to 9 months
- Reasons for discontinuationThe 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.Timeframe: Up to 9 months
- Change in laboratory values from baselinefor hemoglobin, platelets, neutrophilsTimeframe: Up to 9 months
- Radiological progression free survival (rPFS)change in laboratory values from baseline for radiological progression free survival (rPFS)Timeframe: Up to 9 months
- Time to alkaline phosphatase (ALP) progressionchange in laboratory values from baseline for ALPTimeframe: Up to 9 months
- Time to visceral metastasistime from baseline to the appearance of visceral metastasisTimeframe: Up to 9 months
- Time to onset of first subsequent treatmentor start of any other treatment for mCRPCTimeframe: Up to 9 months
- PainBased on chart reported painTimeframe: Up to 9 months
- Most common symptomsThe 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, thrombocytopeniaTimeframe: Up to 9 months
- Type of physicianDefine type of physicians that treat of mCRPCTimeframe: Up to 9 months
- Change in PSA from baseline to 12 weeks, and baseline to discontinuationMeasure PSA closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuationTimeframe: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
- Resource utilizationNumber of outpatient, inpatient and emergency room visits as well as number of hospitalizationsTimeframe: Up to 9 months
- Change in ALP from baseline to 12 weeks, and baseline to discontinuationMeasure ALP closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuationTimeframe: 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 discontinuationMeasure LDH values closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuationTimeframe: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
Additional Information
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