Description of Relugolix Use in Patients With Prostate Cancer Within the VHA
- Registration Number
- NCT06462014
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this real-world study is the learn about the demographics and clinical characteristics of patients with prostate cancer who initiated relugolix
- Detailed Description
Prostate cancer (PC) is the most common cancer and the second leading cause of cancer death among men in the United States. Androgen deprivation therapy (ADT) such as injectable luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide) is the standard of care for PC patients. ADT treatment can suppress testosterone level to castrate level and delay the progression of the disease.
Relugolix is a recently approved oral GnRH antagonist. While the introduction of relugolix has offered a unique opportunity for patients with PC, it's vital to understand how it is being used in real-world.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 500
- Male with ≥ 1 diagnosis for PC
- Had ≥ 2 prescriptions of relugolix on or after the first observed PC diagnosis.
- Index date: the initiation date of relugolix
- At least 18 years old at the index date
- had surgical castration (bilateral orchiectomy) any time before the index date
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Relugolix patients Relugolix Patients who have initiated relugolix
- Primary Outcome Measures
Name Time Method Characterize clinical characteristics of patients intitiating relugolix treatment Up to 1 year prior to initiating relugolix Descriptive analysis of clinical characteristics such as baseline prostate-specific antigen (PSA) value in ng/dL (among available) based on the PSA value on or prior to the index date will be evaluated. Findings will be presented as the mean, standard deviation (SD), median, 25th percentile, 75th percentile, and interquartile range
Characterize patient characteristics initiating relugolix treatment Up to 1 year prior to initiating relugolix Descriptive analysis of baseline characteristics such as age will be defined as of the index date (start of relugolix) and retained in the dataset as a continuous variable. Findings will be presented as the mean, standard deviation (SD), median, 25th percentile, 75th percentile, and interquartile range
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer
🇺🇸New York, New York, United States