Study identification

EU PAS number

EUPAS35544

Study ID

35545

Official title and acronym

Cardiovascular outcomes among patients with castration-resistant prostate cancer: A comparative safety study within US real world databases

DARWIN EU® study

No

Study countries

United States

Study description

The proposed study will include clinical characterization and population-level effect estimation (observational causal inference) of men with castrate resistant prostate cancer using administrative claims databases which include nation-wide samples of patients insured in the United States (US). We plan to conduct a new user comparative cohort design to compare incidence of myocardial infarction and stroke among men with castrate resistant prostate cancer who are initiating treatment with either abiraterone acetate plus prednisone or enzalutamide. The study period will begin after August 31, 2012 since before that date enzalutamide was not FDA-approved for the treatment of CRPC in the US. Following completion of a feasibility analysis in which we will assess diagnostics to see whether comparisons between abiraterone and enzalutamide are possible, we will compare incidence of various outcomes including ischemic stroke, hemorrhagic stroke, heart failure, and acute myocardial infarction. Patients within each treatment cohort will be described including demographics, conditions, drugs, and procedures used in the time preceding the index date. For calculation of incidence rates, the number of persons with each event, the incidence proportion, and the incidence rate adjusted for person-time according to each at-risk time window for each study population and each of the outcomes of interest will be reported. For the purpose of contextualizing the event rates and quantifying relative risk while controlling for additional confounding factors, a new user cohort design will be used to conduct comparative analyses if the exposed (abiraterone) population can be appropriately matched to the selected comparator population (enzalutamide) based on a defined set of patient and clinical characteristics, using propensity score matching. Cox proportional hazards will be used to estimate the hazards of each outcome in the target cohort, relative to the comparator cohort.

Study status

Planned
Research institutions and networks

Institutions

Contact details

Dina Gifkins

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Janssen
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable