NCT06151418Completed
A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces
Novel Hormonal Therapy (NHT) for Treating Patients With Metastatic Castration-Sensitive Prostate Cancer (mCSPC): An Analysis of National Veterans Affairs Health Care Network Data
Source: ClinicalTrials.gov · Last updated 4 Jun 2025
Brief summary (registry, in English)
The purpose of this study is to learn about- for how long are NHTs taken by men to treat mCSPC. NHTs in this study include study medicines: * abiraterone, * apalutamide, * 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. Most prostate cancers need male hormones to grow. When cancer cells respond to treatment that lowers male hormones, this is known as castration-sensitive prostate cancer. 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 National Veteran's Affairs (VA) Health Care Network. The study will include patients' information from the database for men who: * were identified to have mCSPC. * started treatment with NHT for mCSPC. * were 18 years of age or older at start of NHT. Men in this study will be taking NHT for treatment of their mCSPC. The study will explain: * how long men take the therapy. * how long it takes to start next therapy. This study will use patient information about medications and treatments from VA data. This study will use information one year before start of NHT until information is available.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 2313 (actual)
- First submitted
- 21 Nov 2023
- Start date
- 22 Nov 2023
- Primary completion date
- 23 Apr 2024
- Lead sponsor
- Pfizer
- Diseases
- Prostate cancer
- NCT number
- NCT06151418
What you commit to
- Study type: Observational
- Participants enrolled: 2313
- From 22 Nov 2023 to the primary completion date, 23 Apr 2024
- 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 other prostate cancer treatment including NHT, non-steroidal anti-androgen (NSAA), chemotherapy, immunotherapy, radium 223, lutetium Lu 177 vipivotide tetraxetan, ketoconazole, or PARP inhibitor prior to the index date
- Had diagnosis code indicating hormone resistance prior to the index date
- A rise in prostate-specific antigen from the nadir by ≥2 ng/mL after castration
- Participation in a clinical trial during the 30 days before the index date
Other illness
- Had a prior history of other cancers (except non-melanoma skin cancer)
Who the study is looking for
- Male with ≥ 1 diagnosis claim for prostate cancer
- Had documented secondary metastasis code on or after the initial prostate cancer diagnosis
- Had initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 90 days prior to the metastasis date or on or after the metastasis date. The initiation date of the earliest novel hormonal therapy will be defined as the index date
- ≥18 years old on index date
- Continuous enrollment for at least 365 days before index date
- Evidence to be castration-sensitive:
- No prior surgical castration any time prior to the index date or no medical castration with ≥8 weeks of continuous use within -90 to -365 days prior to the index date, OR
- Diagnosis of hormone sensitive malignancy status within 90 days before the index date
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.