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Trial record 84 of 2758 for:    prostate cancer AND Cancer | ( Map: United States )

Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases in a Medicare Population

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ClinicalTrials.gov Identifier: NCT02518698
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
The goal of the study is to provide a detailed description of treatments for CRPC (Castrate Resistant Prostate Cancer) patients with bone metastases and the resource utilization and costs associated with that diagnosis and subsequent treatments.

Condition or disease Intervention/treatment
Prostate Cancer Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

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Study Type : Observational
Actual Enrollment : 1163 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases
Actual Study Start Date : August 31, 2015
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Cohort 1 / Treatment patterns
Patients with castrated resistant prostate cancer and bone metastases
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Therapies used to treat prostate cancer and more specifically castrate resistant prostate cancer inclusively Xofigo (Radium-223 dichloride, BAY88-8223)




Primary Outcome Measures :
  1. Overall survival of mCRPC patients [ Time Frame: Up to 24 months ]
    mCRPC: Metastatic castrate-resistant prostate cancer

  2. Number of skeletal related events (SREs) of the mCRPC patients [ Time Frame: Up to 30 months ]
  3. Type of skeletal related events (SREs) of the mCRPC patients [ Time Frame: Up to 30 months ]
  4. Number of patients with mCRPC with bone metastases [ Time Frame: Up to 24 months ]
  5. Type of treatments associated with mCRPC [ Time Frame: Up to 24 months ]
    Treatments could include chemotherapy or bone radiation

  6. Duration for each treatment identified [ Time Frame: Up to 30 months ]
  7. Distribution of providers by treatment [ Time Frame: Up to 30 months ]
    Distribution of treatments for mCRPC patients will be tracked by the type of provider (oncologist, versus urologist, versus radiation oncologist, etc)

  8. Clinical and demographic characteristics of the mCRPC patients [ Time Frame: Up to 12 months ]
    Gender, age, geographical region and race/ethnicity, Key comorbidities will also be documented using the Deyo-Charlson Comorbidity Index (DCCI); laboratory results for Prostate-Specific Antigen (PSA) and alkaline phosphatase (ALP) testing using laboratory claims; Rx utilization including opioid use

  9. Treatment patterns of mCRPC patients with bone metastases [ Time Frame: Up to 30 months ]
  10. Progression of the disease of mCRPC patients [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. All-cause healthcare resource utilization for mCRPC patients [ Time Frame: Up to 30 months ]
    Using all post-index medical and pharmacy claims, compute the count of physician office visits, outpatient services, inpatient stay, length of inpatient stay, ancillary services, and count of pharmacy claims

  2. mCRPC-specific healthcare resource utilization for mCRPC patients [ Time Frame: Up to 30 months ]
    Healthcare resource utilization will be measured using all post-index medical and pharmacy claims to create counts for physician office visits, outpatient services, inpatient stay, length of inpatient stay, ancillary services and counts of pharmacy claims

  3. All-cause healthcare costs for mCRPC patients [ Time Frame: Up to 30 months ]
    Healthcare costs will be determined using all post-index medical and pharmacy claims. The all-cause total (medical + pharmacy), medical and pharmacy costs will be computed. A family of general linear model analysis will be performed (medical, pharmacy, and total costs)

  4. mCRPC-specific healthcare costs for mCRPC patients [ Time Frame: Up to 30 months ]
    Healthcare costs will be determined using all post-index medical and pharmacy claims where a diagnosis of mCRPC appears in any of the nine diagnosis positions. The mCRPC specific total (Medical + pharmacy), medical and pharmacy costs associated with these claims will be computed.



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Ages Eligible for Study:   55 Years to 88 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Castrated resistant prostate cancer patients with bone metastases
Criteria

Inclusion Criteria:

  • First diagnosis for bone metastases for members diagnosed with prostate cancer found in the claims data during the identification period
  • Members age ≥ 55 to 89 years at index
  • Medicare members with medical and pharmacy coverage; and
  • Continuously enrolled during the pre- and post-index periods.

Exclusion Criteria:

  • Member with diagnosis of any other cancer (excluding melanoma (ICD-9 172.x) and other metastases (ICD-9 198.x)) before the index date; and
  • Members age ≥ 89 years of age at index date

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518698


Locations
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United States, Kentucky
Louisville, Kentucky, United States
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02518698     History of Changes
Other Study ID Numbers: 18273
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Keywords provided by Bayer:
Castrated resistant prostate cancer
Patients with bone metastases
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Neoplastic Processes
Pathologic Processes
Radium Ra 223 dichloride
Antineoplastic Agents