A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces

Study Overview
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Brief Summary
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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.

Official Title
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Novel Hormonal Therapy (NHT) for Treating Patients With Metastatic Castration-Sensitive Prostate Cancer (mCSPC): An Analysis of National Veterans Affairs Health Care Network Data

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: Novel hormonal therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Had a prior history of other cancers (except non-melanoma skin cancer) Participation in a clinical trial during the 30 days before the index date

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Novel hormonal therapy cohort<br>Patients initiating novel hormonal therapy (abiraterone, apalutamide or enzalutamide) for mCSPC | Drug: Novel hormonal therapy<br>* As provided in real-world setting<br>* Other names: Enzalutamide(Xtandi);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment duration | Duration of therapy will be defined as the time from the index date to the date of novel hormonal therapy (NHT) discontinuation for any reason. Discontinuation of the current NHT will be defined as a treatment gap of at least 90 days (the last day with days supply before the gap as discontinuation date), the initiation of a new therapy, or death, whichever comes first. | Up to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to next therapy | Time to next therapy will be defined as the time from the index date to the initiation date of a new therapy. Patients who do not initiate a new therapy will be censored at the end of data availability or death, whichever comes first. | Up to 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic castration-sensitive prostate cancer, mCSPC, metastatic hormone-sensitive prostate cancer, mHSPC, enzalutamide, abiraterone, treatment duration, time to next therapy