A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Study Overview
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Brief Summary
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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.

Official Title
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Novel Hormonal Therapies (NHTs) for the Treatment of Metastatic Castration-sensitive Prostate Cancer (mCSPC) in the Medicare Population

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 Have documented secondary metastasis code on or after the initial prostate cancer diagnosis Have initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 30 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. Have a claim for androgen deprivation therapy (ADT) within 90 days prior to or within 30 days after the index date ≥65 years old 12 months prior to the index date Continuous enrollment in Medicare Parts A, B, and D for ≥12 months prior to the index date and ≥6 months following the index date (unless death) Exclusion Criteria: Claims indicating ≥8 weeks of continuous ADT use between 90 and 365 days prior to the index date, which may indicate castration-resistance Received chemotherapy, novel hormonal therapy, radium-223, PARP inhibitor, immunotherapy, or surgical castration prior to the index date Had a prior history of other cancers

Ages Eligible for Study
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Minimum Age: 65 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 | Treatment duration will be defined as the time from the initiation of novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) to the discontinuation date. Discontinuation will be defined as the earliest of 1) death, 2) last observed pharmacy claim plus days of supply associated with last claim, 3) day before the start of next line of therapy, or 4) end of data availability. | Up to approximately 55 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