Description of Relugolix Use in Patients With Prostate Cancer Within the VHA

Prostate Cancer Clinical Trial

Official title:

Description of Relugolix Use in Patients With Prostate Cancer: An Analysis of National Veterans Affairs Health Care Network Data

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06462014
• Other study ID #: C4751009
• Secondary ID: VHA Study
• Status: Not yet recruiting
• Start date: June 28, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• had surgical castration (bilateral orchiectomy) any time before the index date

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Relugolix
relugolix

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize patient characteristics initiating relugolix treatment	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	Up to 1 year prior to initiating relugolix
Primary	Characterize clinical characteristics of patients intitiating relugolix treatment	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	Up to 1 year prior to initiating relugolix