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Trial Title:
A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer
NCT ID:
NCT05968599
Condition:
Prostatic Neoplasms, Castration-Resistant
Conditions: Official terms:
Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Abiraterone Acetate
Conditions: Keywords:
metastatic castration-resistant prostate cancer
mCRPC
enzalutamide
abiraterone
overall survival
OS
treatment duration
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Enzalutamide
Description:
As provided in real-world setting
Arm group label:
Enzalutamide cohort
Other name:
Xtandi
Intervention type:
Drug
Intervention name:
Abiraterone acetate
Description:
As provided in real-world setting
Arm group label:
Abiraterone cohort
Other name:
Yonsa, Zytiga
Summary:
The purpose of this real-world study is to learn about the effects of 2 study medicines
called enzalutamide and abiraterone used to treat metastatic castration-resistant
prostate cancer (mCRPC).
Prostate cancer is one of the most common cancers in men. The prostate is a gland in the
male body that helps make semen. Most prostate cancers need male sex hormones, such as
testosterone, to grow. Prostate cancer that keeps growing even when the amount of
testosterone in the body is reduced to very low levels is known as
"castration-resistant". Metastatic cancer is a cancer that has spread to other parts of
the body.
This is a real-world study, not a clinical trial. This means that researchers will look
at what happens when men receive the treatments prescribed by their own doctor as part of
their usual healthcare treatment. In this study, researchers will use information from
the Flatiron Electronic Health Record (EHR) database.
The study will include patients' information from the database for men who:
- Were confirmed by medical tests to have mCRPC
- Started first-line treatment with enzalutamide or abiraterone (index date) for mCRPC
- Had not received chemotherapy treatment before index date
- Were 18 years of age or older on index date
Men who are part of this study will receive enzalutamide or abiraterone as part of their
usual treatment for mCRPC.
We will compare the following between men receiving enzalutamide and men receiving
abiraterone:
- time from treatment start until death,
- treatment duration, and
- time to next treatment. This study will use patient information from the database
until the end of information that is available.
Criteria for eligibility:
Study pop:
Men with chemotherapy-naïve mCRPC (aged ≥18 years) who initiated enzalutamide or
abiraterone and met eligibility criteria will be included in the study. Patients will be
identified from the Flatiron EHR database.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Male with metastatic prostate cancer diagnosis and abstracted castration-resistant
prostate cancer diagnosis
- Initiated enzalutamide or abiraterone within 14 days prior to or after the
metastatic castration-resistant prostate cancer diagnosis. The initiation date of
enzalutamide or abiraterone will be defined as the index date.
- At least 18 years old at the index date
Exclusion Criteria:
- Received chemotherapy, novel hormonal therapy, radium-223, olaparib/rucaparib, or
immunotherapy prior to the index date
- Had a prior history of other cancers
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Pfizer Inc
Address:
City:
New York
Zip:
10001
Country:
United States
Start date:
July 24, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Collaborator:
Agency:
Astellas Pharma Inc
Agency class:
Industry
Source:
Pfizer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05968599
https://pmiform.com/clinical-trial-info-request?StudyID=C3431047
