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Trial record 1 of 1 for:    NCT02702908
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Second Primary Cancers in Patients With Castration Resistant Prostate Cancer (BOCARP)

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ClinicalTrials.gov Identifier: NCT02702908
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
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.

Condition or disease
Prostatic Neoplasms

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 Design
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Study Type : Observational
Actual Enrollment : 6442 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Second Primary Cancers in Patients With Castration Resistant Prostate Cancer (BOCARP)
Actual Study Start Date : March 15, 2016
Actual Primary Completion Date : October 20, 2017
Actual Study Completion Date : October 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Group/Cohort
mPC
Prostate cancer patients with bone metastases (mPC)
mCRPC
Patients with castration-resistant prostate cancer with bone metastases (mCRPC)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 10 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).
Criteria

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)
Contacts and Locations
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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): NCT02702908


Locations
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Germany
Multiple Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02702908    
Other Study ID Numbers: 18044
EUPAS12665 ( Registry Identifier: ENCEPP )
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms, Second Primary
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases