Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )
Navigant
Current Management, Treatment Patterns and Outcomes of Metastatic Castrate Resistant Prostate Cancer Patients Treated With Radium-223
1 other identifier
observational
200
1 country
1
Brief Summary
Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2016
CompletedFirst Posted
Study publicly available on registry
September 14, 2016
CompletedStudy Start
First participant enrolled
June 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2019
CompletedMarch 31, 2020
March 1, 2020
1.8 years
July 19, 2016
March 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (23)
Most common treatment sequences
Up to 9 months
Integration of Xofigo into the common treatment sequences, monotherapy or in combination.
Up to 9 months
Mean Xofigo dose
Up to 9 months
Duration of Xofigo treatment
Up to 9 months
Overall survival (OS)
Up to 9 months
- +18 more secondary outcomes
Study Arms (1)
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.
Interventions
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.
Eligibility Criteria
mCRPC patients treated with Xofigo from 10 centers in the US
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Whippany
Whippany, New Jersey, 07981, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2016
First Posted
September 14, 2016
Study Start
June 15, 2017
Primary Completion
March 31, 2019
Study Completion
March 31, 2019
Last Updated
March 31, 2020
Record last verified: 2020-03