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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06151418
• Other study ID #: C3431052
• Status: Active, not recruiting
• Start date: November 22, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: March 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- 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

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	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	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

External Links

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