Clinical trial NCT02899104: Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )
Official title: Current Management, Treatment Patterns and Outcomes of Metastatic Castrate Resistant Prostate Cancer Patients Treated With Radium-223
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms, Castration-Resistant
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-09-14
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: mCRPC patients treated with Xofigo from 10 centers in the US

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determining factors that drive physician decision for treatment selection.
timeFrame: Up to 9 months
Secondary outcomes:
measure: Most common treatment sequences
timeFrame: Up to 9 months
measure: Integration of Xofigo into the common treatment sequences, monotherapy or in combination.
timeFrame: Up to 9 months
measure: Mean Xofigo dose
timeFrame: Up to 9 months
measure: Duration of Xofigo treatment
timeFrame: Up to 9 months
measure: Overall survival (OS)
timeFrame: Up to 9 months
measure: Time to radiographic progression
timeFrame: Up to 9 months
measure: Time to PSA (Prostate specific antigen) progression
timeFrame: Up to 9 months
measure: Most common SRE (Skeletal Related Event)
timeFrame: Up to 9 months
measure: Most common clinical intervention
timeFrame: Up to 9 months
measure: Time to first SSE(Symptomatic Skeletal Events)
timeFrame: Up to 9 months
measure: Reasons for discontinuation
timeFrame: Up to 9 months
measure: Change in laboratory values from baseline
timeFrame: Up to 9 months
measure: Radiological progression free survival (rPFS)
timeFrame: Up to 9 months
measure: Time to alkaline phosphatase (ALP) progression
timeFrame: Up to 9 months
measure: Time to visceral metastasis
timeFrame: Up to 9 months
measure: Time to onset of first subsequent treatment
timeFrame: Up to 9 months
measure: Pain
timeFrame: Up to 9 months
measure: Most common symptoms
timeFrame: Up to 9 months
measure: Type of physician
timeFrame: Up to 9 months
measure: Change in PSA from baseline to 12 weeks, and baseline to discontinuation
timeFrame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
measure: Resource utilization
timeFrame: Up to 9 months
measure: Change in ALP from baseline to 12 weeks, and baseline to discontinuation
timeFrame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
measure: Change in LDH from baseline to 12 weeks, and baseline to discontinuation
timeFrame: Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
Other outcomes:
Locations:
city: Whippany
country: United States
facility: Whippany
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: