Clinical trial NCT06151418: A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Keywords: metastatic castration-sensitive prostate cancer
mCSPC
metastatic hormone-sensitive prostate cancer
mHSPC
enzalutamide
abiraterone
treatment duration
time to next therapy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Inc
First posted: 2023-11-30
Enrollment: 2313
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with metastatic castration-sensitive prostate cancer who initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) and met eligibility criteria will be included in the study. Patients will be identified from the National Veterans Affairs Health Care Network.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Duration of Therapy (DOT)
timeFrame: From start of index treatment to date of NHT discontinuation or censoring date, whichever came first, during maximum follow-up of 45 months
Secondary outcomes:
measure: Time to Next Therapy (TTNT)
timeFrame: From start of index treatment until date of new therapy, or censoring date, whichever came first; during maximum follow-up of 45 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer Inc
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: