Status:
COMPLETED
A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces
Lead Sponsor:
Pfizer
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
18+ years
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 can...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 22 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 23 2024
Estimated Enrollment :
2313 Patients enrolled
Trial Details
Trial ID
NCT06151418
Start Date
November 22 2023
End Date
April 23 2024
Last Update
June 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Inc
New York, New York, United States, 10001