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NCT06072196 · ClinicalTrials.gov registry record
A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
A clinical trial, sponsored by Pfizer.
- Completed
- Registry status
- 3,017
- Enrollment target
NCT06072196: Completed study, sponsored by Pfizer.
NCT06072196 is a clinical trial that has completed, run by Pfizer. The registered enrollment target is 3,017 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06072196 has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- 3,017 participants
- Enrollment target
Study Summary
The purpose of this study is to learn about how long novel hormonal therapies are taken by men to treat mCSPC. Novel hormonal therapies in this study include study medicines abiraterone, apalutamide, and enzalutamide. Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Metastatic cancer is a cancer that has spread to other parts of the body. Castration-sensitive prostate cancer means the cancer is being controlled by keeping the testosterone levels as low as would be expected if the testicles were removed by surgery. 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 insurance claim information from Medicare claims data. The study will include patients' information from the database for men who: * Were identified to have mCSPC. * Started treatment with novel hormonal therapy (index date) for mCSPC. * Were 65 years of age or older one year before index date. Men in this study will be taking novel hormonal therapy for treatment of their mCSPC. We will describe how long men take novel hormonal therapy. This study will use patient information from insurance claims. It will take information one year before start of novel hormonal treatment until the end of insurance period or until information is available.
Primary Outcome
Treatment duration was defined as the time from the initial claim date of NHT (abiraterone, apalutamide, or enzalutamide) until the end of observation for any of the following reasons: (i) end of data availability (December 31, 2022), (ii) participant's date of death, (iii) day before a treatment switch, (iv) day of treatment discontinuation (a 90-day gap in days supply was considered as discontinuation). Retrospective retrieved data collected was evaluated for approximately 1.2 years of this st
Interventions
- DRUG Novel hormonal therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,017 participants |
| Start Date | 2023-10-04 |
| Est. Completion | 2024-12-18 |
What the finished NCT06072196 record still lists
NCT06072196 is an observational study that tracks outcomes without assigning an intervention. Its 3,017 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Novel hormonal therapy is the first listed.
NCT06072196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06072196 about?
NCT06072196 is a clinical study titled "A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)". The purpose of this study is to learn about how long novel hormonal therapies are taken by men to treat mCSPC. Novel hormonal therapies in this study include study medicines abiraterone, apalutamide, and enzalutamide. Prostate cancer is one of the most common cancers in men. The prostate is a gland...
What is the current status of trial NCT06072196?
This trial is currently completed. The enrollment target is 3,017 participants. The study started on 2023-10-04. Estimated completion is 2024-12-18.
What interventions are being tested in trial NCT06072196?
The interventions under investigation include: Novel hormonal therapy (DRUG).
Who is sponsoring clinical trial NCT06072196?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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