NCT07086651Completed
A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC)
Real-world Clinical Outcomes With Androgen Receptor Pathway Inhibitors (ARPIs) in Metastatic Castration-sensitive Prostate Cancer (mCSPC) in the Flatiron Health Electronic Health Records (EHR) Database
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
The purpose of this study is to learn about how long apalutamide and enzalutamide are taken by men to treat mCSPC. 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 study. 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 cancer clinics (Flatiron Health electronic health records). The study will include patients' information from the database for men who: * Were identified to have mCSPC. * Started treatment with apalutamide or enzalutamide (index date) for mCSPC. * Were 18 years of age or older on the index date. Men in this study will be taking apalutamide or enzalutamide for treatment of their mCSPC. The study will compare how long men take apalutamide or enzalutamide. This study will use patient information from cancer clinics. Information from start of apalutamide or enzalutamide treatment until information is available in the database will be used to describe how long patients receive treatment.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1300 (actual)
- First submitted
- 18 Jul 2025
- Start date
- 21 Jul 2025
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Pfizer
- Diseases
- Prostate cancer
- NCT number
- NCT07086651
What you commit to
- Study type: Observational
- Participants enrolled: 1300
- From 21 Jul 2025 to the primary completion date, 31 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Evidence of castration-resistance prior to the index date
- Received chemotherapy, androgen receptor pathway inhibitor, radiopharmaceuticals, immunotherapy, PARP inhibitor, or estrogens prior to the index date
- Evidence of ADT use between 1 year and 91 days prior to the index date
Other illness
- Had a prior history of other cancers
Who the study is looking for
- Male patients diagnosed with metastatic prostate cancer
- Initiated apalutamide or enzalutamide for the first-line treatment of metastatic castration-sensitive prostate cancer (mCSPC). Initiation date of first treatment defines the index date.
- Index date on or after 1 January 2020
- Evidence of androgen deprivation therapy (ADT) use between 90 days prior to the index date and 6 months following the index date
- Age ≥18 years on the index date -≥6 months of clinical activity following the index date, unless the patient died
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pfizer Inc Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.