Incidence of Second Primary Malignancies in Castration-Resistant Prostate Cancer: An Observational Retrospective Cohort Study in the US

NCT02788409 | Completed

• 1 other identifier: 18673
• Study Type: observational
• Target: 2,234
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted to estimate population-based incidence rates of second primary malignancies among patients with CRPC similar to those treated with Xofigo. These rates will provide context for second primary malignancy incidence rates from the REASSURE study. Furthermore this study aims to provide further information about the documentation of bone metastases in Medicare data and the extent of use of only oral androgen deprivation drugs among patients with Medicare Part D coverage, as well as to estimate overall survival of the study population.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (2)

• Incidence rate of second primary malignancy

  Retrospective analysis between 1-Jan-2000 and 31-Dec-2013

• Incidence rates of skeletal-related events

  Retrospective analysis between 1-Jan-2000 and 31-Dec-2013

Secondary Outcomes (3)

• Proportion with a history of bone metastasis at cohort entry

  Retrospective analysis between 1-Jan-2000 and 31-Dec-2013

• Proportion who met the definition of castration based solely on Part D data

  Retrospective analysis between 1-Jan-2000 and 31-Dec-2013

• Overall survival

  Retrospective analysis between 1-Jan-2000 and 31-Dec-2013

Study Arms (1)

Medicare CRPC

Men in the US older than 65 years old having CRPC

Other: Not applicable for study

Interventions

Not applicable for study OTHER

Provide external perspective on background second primary cancer incidence rates for REASSURE study.

Medicare CRPC

Eligibility Criteria

• Age: 65 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The cohort will include men who are enrolled in both Medicare Parts A and B for at least 1 year before the cohort entry date, have a primary site code of prostate cancer in SEER data, have surgical castration or androgen deprivation therapy after prostate cancer diagnosis, have evidence that prostate cancer was resistant to the castration as indicated by starting a second-line systemic therapy, and have an cohort entry date of 01 January 2006 or later on which they are aged 65 years or older. All eligible subjects will be selected; there will be no sampling. (The probability of selecting each eligible patient is equal to 1)

You may qualify if:

• Enrolled in both Medicare Parts A and B for at least 1 year before the cohort entry date (minimum lookback period for comorbidities and treatments)
• Primary site code of prostate cancer (International Classification of Diseases for Oncology, Third Edition \[ICD-O-3\] topography code C61.9) in SEER data
• Surgical castration or androgen deprivation therapy after prostate cancer diagnosis; androgen deprivation therapy will be indicated by the use of any of the following drugs: abarelix, bicalutamide, buserelin, cyproterone, degarelix, diethylstilbestrol, estramustine, flutamide, gonadorelin, goserelin, histrelin, leuprolide, medroxyprogesterone, megestrol, nafarelin, nilutamide, polyestradiol, triptorelin
• Evidence that prostate cancer was resistant to surgical castration or androgen deprivation therapy ("castration-resistant prostate cancer"), as indicated by starting one of the following second-line systemic therapies (cohort entry date): abiraterone, cabazitaxel, docetaxel, enzalutamide, mitoxantrone, or sipuleucel-T
• Cohort entry date 01 January 2006 or later
• Age 65 years or older in the US on the cohort entry date

You may not qualify if:

• Enrollment in an HMO (Health Maintenance Organization) in the year before the cohort entry date
• Diagnosis of any cancer other than prostate cancer or nonmelanoma skin cancer on or before the cohort entry date
• Any diagnostic code for metastases other than bone metastases or lymph node metastases on or before the cohort entry date
• Any claim for treatment with Xofigo on or before the cohort entry date.

Sponsors & Collaborators

• Bayer: lead
• RTI Health Solutions: collaborator

Study Sites (1)

Unknown Facility

Waltham, Massachusetts, United States

Location

Related Links

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MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 2, 2016
• Study Start: May 15, 2016
• Primary Completion: May 9, 2018
• Study Completion: May 9, 2018
• Last Updated: May 8, 2019

Record last verified: 2019-05

Locations

US (1)