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

May 7, 2019 updated by: Bayer

Incidence of Second Primary Malignancies in Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

2234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Waltham, Massachusetts, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Medicare CRPC
Men in the US older than 65 years old having CRPC
Other: Not applicable for study
Provide external perspective on background second primary cancer incidence rates for REASSURE study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of second primary malignancy
Time Frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Incidence rates of skeletal-related events
Time Frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Retrospective analysis between 1-Jan-2000 and 31-Dec-2013

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion with a history of bone metastasis at cohort entry
Time Frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
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
Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Overall survival
Time Frame: Retrospective analysis between 1-Jan-2000 and 31-Dec-2013
Retrospective analysis between 1-Jan-2000 and 31-Dec-2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

RTI Health Solutions

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2016

Primary Completion (Actual)

May 9, 2018

Study Completion (Actual)

May 9, 2018

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Actual)

May 8, 2019

Last Update Submitted That Met QC Criteria

May 7, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18673

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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