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NCT05968599 · ClinicalTrials.gov registry record
A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer
A clinical trial, sponsored by Pfizer.
- Completed
- Registry status
- 2,731
- Enrollment target
NCT05968599: Completed study, sponsored by Pfizer.
NCT05968599 is a clinical trial that has completed, run by Pfizer. The registered enrollment target is 2,731 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05968599 has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- 2,731 participants
- Enrollment target
Study 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.
Primary Outcome
OS was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the date of death. Participants who did not die during this period were censored at their last available follow-up, which was defined as the earlier of end of data availability or last participant contact. Index date was defined as the date of initiation of enzalutamide or abiraterone and their index date was required to occur during the index period. Kaplan-Meier (weighted) method was used for an
Interventions
- DRUG Enzalutamide
- DRUG Abiraterone acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,731 participants |
| Start Date | 2023-07-24 |
| Est. Completion | 2025-02-14 |
What the finished NCT05968599 record still lists
NCT05968599 is an observational study that tracks outcomes without assigning an intervention. Its 2,731 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 2 interventions - of which Enzalutamide is the first listed.
NCT05968599 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05968599 about?
NCT05968599 is a clinical study titled "A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer". 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 ...
What is the current status of trial NCT05968599?
This trial is currently completed. The enrollment target is 2,731 participants. The study started on 2023-07-24. Estimated completion is 2025-02-14.
What interventions are being tested in trial NCT05968599?
The interventions under investigation include: Enzalutamide (DRUG), Abiraterone acetate (DRUG).
Who is sponsoring clinical trial NCT05968599?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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