Clinical Trial: Navigant Study- Treatment Patterns in mCRPC (Metastatic Castrate Resistant Prostate Cancer )

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Current Management, Treatment Patterns and Outcomes of Metastatic Castrate Resistant Prostate Cancer Patients Treated With Radium-223

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 Summary: This is a chart review of 200 Xofigo patients to describe sequencing and characterize clinical parameters and patient determinants that drive physician decision making.
Sponsor: Bayer

Current Primary Outcome: Determining factors that drive physician decision for treatment selection. [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Most common treatment sequences [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: Up to 9 months ]
    Mean dose of each treatment received in the respective sequence
  • Duration of Xofigo treatment [ Time Frame: Up to 9 months ]
    Mean number of treatment cycles
  • Overall survival (OS) [ Time Frame: Up to 9 months ]
    Collect outcomes for patients following treatment for mCRPC including changes in overall survival
  • Time to radiographic progression [ Time Frame: 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 [ Time Frame: Up to 9 months ]
    Collect outcomes for patients following treatment for mCRPC including changes in PSA progression
  • Most common SRE (Skeletal Related Event) [ Time Frame: Up to 9 months ]
    The SRE occurring in the highest number of participants will be described.
  • Most common clinical intervention [ Time Frame: 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) [ Time Frame: Up to 9 months ]
    Time to first SSE outcome will be analysed using the Kaplan Meier method
  • Reasons for discontinuation [ Time Frame: 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 [ Time Frame: Up to 9 months ]
    for hemoglobin, platelets, neutrophils
  • Radiological progression free survival (rPFS) [ Time Frame: Up to 9 months ]
    change in laboratory values from baseline for radiological progression free survival (rPFS)
  • Time to alkaline phosphatase (ALP) progression [ Time Frame: Up to 9 months ]
    change in laboratory values from baseline for ALP
  • Time to visceral metastasis [ Time Frame: Up to 9 months ]
    time from baseline to the appearance of visceral metastasis
  • Time to onset of first subsequent treatment [ Time Frame: Up to 9 months ]
    or start of any other treatment for mCRPC
  • Pain [ Time Frame: Up to 9 months ]
    Based on chart reported pain
  • Most common symptoms [ Time Frame: 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 [ Time Frame: Up to 9 months ]
    Define type of physicians that treat of mCRPC
  • Change in PSA from baseline to 12 weeks, and baseline to discontinuation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 discontinu

    Original Secondary Outcome:

    • Most common treatment sequences [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: Up to 9 months ]
    • Duration of Xofigo treatment [ Time Frame: Up to 9 months ]
      Mean number of treatment cycles
    • Overall survival (OS) [ Time Frame: Up to 9 months ]
    • Time to radiographic progression [ Time Frame: Up to 9 months ]
    • Time to PSA (Prostate specific antigen) progression [ Time Frame: Up to 9 months ]
    • Most common SRE (Skeletal Related Event) [ Time Frame: Up to 9 months ]
      The SRE occurring in the highest number of participants will be described.
    • Most common clinical intervention [ Time Frame: 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) [ Time Frame: Up to 9 months ]
    • Reasons for discontinuation [ Time Frame: 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 [ Time Frame: Up to 9 months ]
      for hemoglobin, platelets, neutrophils
    • Radiological progression free survival (rPFS) [ Time Frame: Up to 9 months ]
    • Time to alkaline phosphatase (ALP) progression [ Time Frame: Up to 9 months ]
    • Time to visceral metastasis [ Time Frame: Up to 9 months ]
    • Time to onset of first subsequent treatment [ Time Frame: Up to 9 months ]
      or start of any other anticancer treatment
    • Pain [ Time Frame: Up to 9 months ]
      Based on chart reported pain
    • Most common symptoms [ Time Frame: 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 [ Time Frame: Up to 9 months ]
      Define type of physicians that treat of mCRPC
    • Change in PSA from baseline to 12 weeks, and baseline to discontinuation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


    Information By: Bayer

    Dates:
    Date Received: July 19, 2016
    Date Started: July 31, 2017
    Date Completion: August 31, 2017
    Last Updated: May 15, 2017
    Last Verified: May 2017