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NCT Number: NCT02788409

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Waltham, Massachusetts, United States

About this study

Xofigo (radium-223 dichloride) is an alpha-emitting pharmaceutical, which was approved for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastatic disease. The long-term safety profile of Xofigo is evaluated in the prospective REASSURE study, which estimates the incidence rates of second primary malignancies in patients with CRPC receiving Xofigo.

To provide context on that, this retrospective study is conducted to estimate background rates of second primary malignancies among patients with CRPC similar to those who are treated with Xofigo.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Not applicable for study

Other

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

Primary outcomes

  1. Incidence rate of second primary malignancy

    Time frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013

  2. Incidence rates of skeletal-related events

    Time frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013

Secondary outcomes

  1. Proportion with a history of bone metastasis at cohort entry

    Time frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013

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

    Time frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013

  3. Overall survival

    Time frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • RTI Health Solutions

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 2, 2016
Registry last updated
May 8, 2019

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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