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Completed

NCT Number: NCT02899104

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

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

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Key information

Conditions

Prostatic Neoplasms, Castration-Resistant Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Whippany

Whippany, New Jersey, 07981, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xofigo (Radium-223 dichloride, BAY88-8223)

Drug

Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. Mean Xofigo dose

    Time frame: Up to 9 months

    Mean dose of each treatment received in the respective sequence

  4. Duration of Xofigo treatment

    Time frame: Up to 9 months

    Mean number of treatment cycles

  5. Overall survival (OS)

    Time frame: Up to 9 months

    Collect outcomes for patients following treatment for mCRPC including changes in overall survival

  6. 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

  7. 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

  8. Most common SRE (Skeletal Related Event)

    Time frame: Up to 9 months

    The SRE occurring in the highest number of participants will be described.

  9. Most common clinical intervention

    Time frame: Up to 9 months

    Most common clinical intervention to treat SRE/SSEs such as radiation or bone surgery.

  10. 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

  11. 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.

  12. Change in laboratory values from baseline

    Time frame: Up to 9 months

    for hemoglobin, platelets, neutrophils

  13. Radiological progression free survival (rPFS)

    Time frame: Up to 9 months

    change in laboratory values from baseline for radiological progression free survival (rPFS)

  14. Time to alkaline phosphatase (ALP) progression

    Time frame: Up to 9 months

    change in laboratory values from baseline for ALP

  15. Time to visceral metastasis

    Time frame: Up to 9 months

    time from baseline to the appearance of visceral metastasis

  16. Time to onset of first subsequent treatment

    Time frame: Up to 9 months

    or start of any other treatment for mCRPC

  17. Pain

    Time frame: Up to 9 months

    Based on chart reported pain

  18. 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

  19. Type of physician

    Time frame: Up to 9 months

    Define type of physicians that treat of mCRPC

  20. 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

  21. Resource utilization

    Time frame: Up to 9 months

    Number of outpatient, inpatient and emergency room visits as well as number of hospitalizations

  22. 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

  23. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: Navigant

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 14, 2016
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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