check_circleStudy Completed

Prostatic Neoplasms, Castration-Resistant

Bayer Identifier:

18919

ClinicalTrials.gov Identifier:

NCT02899104

EudraCT Number:

Not Available

EU CT Number:

Not Available
Navigant study- treatment patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )

Trial purpose

Categorize the clinical parameters and patient determinants that drive physician decision making for treatment selection including Radium-223 for patients with mCRPC.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - 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.

  • - 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
June 2017 - March 2019
Phase
N/A
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
WhippanyWhippany, 07981, United States

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.
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Most common treatment sequences
    Description of what treatments are given to treat mCRPC in first, second, third, and fourth line.
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • 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 monotherapy
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean Xofigo dose
    Mean dose of each treatment received in the respective sequence
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Duration of Xofigo treatment
    Mean number of treatment cycles
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Overall survival (OS)
    Collect outcomes for patients following treatment for mCRPC including changes in overall survival
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to radiographic progression
    Collect outcomes for patients following treatment for mCRPC including changes in time to radiographic progression
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to PSA (Prostate specific antigen) progression
    Collect outcomes for patients following treatment for mCRPC including changes in PSA progression
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Most common SRE (Skeletal Related Event)
    The SRE occurring in the highest number of participants will be described.
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Most common clinical intervention
    Most common clinical intervention to treat SRE/SSEs such as radiation or bone surgery.
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to first SSE(Symptomatic Skeletal Events)
    Time to first SSE outcome will be analysed using the Kaplan Meier method
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Reasons for discontinuation
    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.
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Change in laboratory values from baseline
    for hemoglobin, platelets, neutrophils
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Radiological progression free survival (rPFS)
    change in laboratory values from baseline for radiological progression free survival (rPFS)
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to alkaline phosphatase (ALP) progression
    change in laboratory values from baseline for ALP
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to visceral metastasis
    time from baseline to the appearance of visceral metastasis
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to onset of first subsequent treatment
    or start of any other treatment for mCRPC
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Pain
    Based on chart reported pain
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Most common symptoms
    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
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Type of physician
    Define type of physicians that treat of mCRPC
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in PSA from baseline to 12 weeks, and baseline to discontinuation
    Measure PSA closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation
    date_rangeTime Frame:
    Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Resource utilization
    Number of outpatient, inpatient and emergency room visits as well as number of hospitalizations
    date_rangeTime Frame:
    Up to 9 months
    enhanced_encryption
    Safety Issue:
    No
  • Change in ALP from baseline to 12 weeks, and baseline to discontinuation
    Measure ALP closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation
    date_rangeTime Frame:
    Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Change in LDH from baseline to 12 weeks, and baseline to discontinuation
    Measure LDH values closed to the time of Xofigo initiation, 12 weeks after initiation and after discontinuation
    date_rangeTime Frame:
    Baseline and 12 weeks,Baseline and through study completion, an average of 1 year
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information