Status: Finalised
First registered on:
05/05/2018
Last updated on:
28/02/2019
1. Study identification
EU PAS Register NumberEUPAS23879
Official titleUse of degarelix among patients with prostate cancer in daily practice
Study title acronymnone
Study typeObservational study
Brief description of the studyA population-based cohort study will be carried out using the UK’s general practitioner database, Optimum Patient Care Research Database (OPCRD), which includes prostate cancer patients initiating treatment of degarelix, leuprorelin, goserelin or triptorelin from 2010 till present. In this study, we will describe the characteristics, cardio events and urinary tract infections among patients with prostate cancer using degarelix, leuprorelin, goserelin or triptorelin in UK’s primary care.
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
Department/Research groupObservational and Pragmatic Research Institute Pte Ltd
Organisation/affiliationOPRI Pte Ltd
Details of (Primary) lead investigator
Title Professor
Last name Price
First name David
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
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/02/201801/02/2018
Start date of data collection20/03/201820/03/2018
Start date of data analysis30/04/201808/05/2018
Date of interim report, if expected
Date of final study report31/05/201822/05/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherHarvey Walsh100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 15a Coles Lane
Address line 2Oakington
Address line 3
CityCambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)441223967582
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name David
Address line 15a Coles Lane
Address line 2Oakington
Address line 3
CityCambridge
PostcodeCB24 3BA
CountryUnited Kingdom
Phone number (incl. country code)441223967582
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Product NameFirmagon
CountryUnited Kingdom
Substance INN(s)DEGARELIX
7. Medical conditions to be studied
Medical condition(s)No
8. Population under study
Age
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
9. Number of subjects
Estimated total number of subjects8825
Additional information
Degarelix N=97
Leuprorelin N=2836
Goserelin N=4042
Triptorelin N=2836
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
The aim of the study is to describe the use of degarelix among patients with prostate cancer in UK’s primary care.
Are there primary outcomes?Yes
the number of ‘switchers’ to second line treatment (leuprorelin, goserelin, triptorelin or degarelix), cardio events and urinary tract infections from the year 2010 till present.
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
Historical cohort database study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
All patients will be followed from the index prescription date up to the date they died, transferred out of general practice, switched to second line treatment, the date of the cardio event, the date of the urinary tract infection, or the end date of data collection, whichever date will come first
15. Data analysis plan
Please provide a brief summary of the analysis method
An exploratory analysis of variables at baseline or during follow-up (switching to second line treatment, cardio events, or urinary tract infections) will be carried out:
Results are reported as:
● Continuous variables:
o Sample size (n) (standard deviation (SD)) and percentage non-missing
o Median and Interquartile Range (25th and 75th percentiles)
● Categorical variables:
o Sample size (n) and percentage non-missing
o Count and percentage by category (distribution)
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
18. Study Results
Not submitted
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
