Second Primary Cancers in Patients With Castration Resistant Prostate Cancer (BOCARP)

January 18, 2018 updated by: Bayer

Second Primary Cancers in Patients With Castration Resistant Prostate Cancer (BOCARP)

This study aims at estimating the incidence of second primary malignancies as well as the overall survival among metastasized prostate cancer (mPC) and metastasized castrate-resistant prostate cancer (mCRPC) patients not treated with radium-223-dichloride.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims at estimating the incidence of second primary malignancies as well as the overall survival among mPC and mCRPC patients not treated with radium-223-dichloride. The source of data for this study will be the German Pharmacoepidemiological Research Database (GePaRD). A retrospective cohort study covering the time period from 2004 to 2013 will be conducted. The study population will comprise CRPC patients developing bone metastases. These patients will be followed up for the occurrence of second primary malignancies, end of study, or death due to any cause. As this study serves as a historical control group for a single-arm observational study, incidence rates of second primary malignancies obtained from these studies will be compared by the standardized incidence ratio using results from this study as a reference.

Study Type

Observational

Enrollment (Actual)

6442

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

  • Germany
      • Multiple Locations, Germany

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of mPC patients (prostate cancer patients with bone metastases) and a subgroup of patients who can be regarded as mCRPC patients (castration-resistant prostate cancer patients with bone metastases).

Description

Inclusion Criteria:

  • Members of the mPC cohort will have to fulfill all of the following criteria:

    • Valid information on sex, age and the region of residence
    • A period of at least 12 months of continuous insurance preceding cohort entry
    • Diagnosis of PC (ICD-10 Code C61) in the study period (01-Jan-2004 to 31-Dec-2011)
    • Diagnosis of bone metastases (ICD-10 Code C79.5) in the enrolment period (01-Jan-2005 to 31-Dec-2011)
    • In addition to the criteria of the mPC cohort, members of the mCRPC will additionally have to fulfill:

    • One of the following in the enrolment period and before or at the same time with bone metastases

      • Discontinuation of the initial chemical castration, change of the agent or modality of the Androgen deprivation therapy (ADT), or start of treatment for advanced Prostate cancer (PC) after the primary ADT.
      • Surgical castration and initiation of ADT treatment
      • Treatment with medication specific to mCRPC.

Exclusion Criteria:

  • Patients will be excluded from the mPC and from the mCRPC populations if they meet one of the following criteria:

    • First PC diagnosis later than 2 months after the diagnosis of bone metastases, or
    • Use of any radiopharmaceuticals for bone metastases (e.g., samarium, strontium, rhenium, radium)

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
mPC
Prostate cancer patients with bone metastases (mPC)
mCRPC
Patients with castration-resistant prostate cancer with bone metastases (mCRPC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidences of Second primary malignancies are characterized by the following ICD-10 codes: C00-C76, C81-C96, D00-D09, D37-D48.
Time Frame: Up to 10 years
Up to 10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: Up to 10 years
Up to 10 years

Collaborators and Investigators

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

Sponsor

Bayer

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)

March 15, 2016

Primary Completion (Actual)

October 20, 2017

Study Completion (Actual)

October 20, 2017

Study Registration Dates

First Submitted

March 4, 2016

First Submitted That Met QC Criteria

March 4, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Actual)

January 19, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18044
  • EUPAS12665 (Registry Identifier: ENCEPP)

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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