Status: Finalised
First registered on:
04/03/2016
Last updated on:
21/11/2018
1. Study identification
EU PAS Register NumberEUPAS12665
Official titleSecond primary cancers in patients with castration resistant prostate cancer (BOCARP)
Study title acronymBOCARP
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBIPS GmbH
Department/Research groupClinical Epidemiology
Organisation/affiliationLeibniz Inst. for Prevention Research and Epidem.
Details of (Primary) lead investigator
Title Dr
Last name Oliver
First name Riedel
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
Germany
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed10/07/201510/07/2015
Start date of data collection15/03/201615/03/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report30/11/201720/10/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Oliver
First name Riedel
Address line 1Achterstraße 30
Address line 2
Address line 3
CityBremen
Postcode28359
CountryGermany
Phone number (incl. country code)4942121856883
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Dr
Last name Oliver
First name Riedel
Address line 1Achterstraße 30
Address line 2
Address line 3
CityBremen
Postcode28359
CountryGermany
Phone number (incl. country code)4942121856883
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Prostate cancer metastatic
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
9. Number of subjects
Estimated total number of subjects2100
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Data sources not registered with ENCePP
German Pharmacoepidemological Research Database, Germany
Sources of data
Administrative database, e.g. claims database
11. Scope of the study
What is the scope of the study?
Background Incidence Study
Primary scope : Background Incidence Study
12. Main objective(s)
What is the main objective of the study?
Incidence of second primary malignancies in patients with castration resistent prostate cancer.
Are there primary outcomes?Yes
Incidences of Second primary malignancies are characterized by the following ICD-10 codes: C00-C76, C81-C96, D00-D09, D37-D48. - Up to 10 years
Are there secondary outcomes?Yes
Overall survival - Up to 10 years
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Follow-up time starts at the date of 1st bone metastasis diagnosis and ends at death, end of study period December 31, 2013 or end of insurance coverage. In the analysis of outcome event (second primary malignancies), follow-up ends when the 1st diagnosis of outcome event occurs.
15. Data analysis plan
Please provide a brief summary of the analysis method
The incidence of second primary malignancies will be calculated. Overall survival will be described. Details on analysis will be described in the Statistical Analysis Plan (SAP).
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
