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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06072196
• Other study ID #: C3431049
• Status: Completed
• Start date: October 4, 2023
• Est. completion date: February 27, 2024

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: February 27, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Prostatic Neoplasms

Intervention

Drug:
• Novel hormonal therapy
As provided in real-world setting

Locations

Country	Name	City	State
United States	Pfizer Inc	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   To obtain contact information for a study center near you, click here.