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

NCT06462014 | Completed Results

• 2 other identifiers: C4751009VHA Study
• Study Type: observational
• Target: 507
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Keywords

Relugolix

Outcome Measures

Primary Outcomes (11)

• Number of Participants According to Geographic Region

  The number of participants according to geographic regions of the United States (South, West, Northeast and Midwest) as documented during baseline period were reported in this outcome measure. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.

  Baseline period = Up to 1 year prior to index date; available data observed retrospectively over 178 days in this study

• Number of Participants According to Index Year

  Number of participants according to index year (2020, 2021, 2022 and 2023) were reported in this outcome measure. The index date was defined as the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.

  At Index date (anytime between 18-Dec-2020 to 31-Dec- 2023 [approximately 3 years]; available data observed retrospectively over 178 days in this study

• Time From First Observed Prostate Cancer Diagnosis Date to the Index Date

  Time from the first observed prostate cancer date to the index date was evaluated. All data available prior to the index date were used. The index date was defined as the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis. Participants with a diagnosis of prostate cancer between 01-Jan-2006 to 31-Dec-2023 were considered.

  From prostate cancer diagnosis to index date (approximately maximum up to 18 years); available data observed retrospectively over 178 days in this study

• Number of Participants According to Type of Previous Treatments Received

  Number of participants according to treatments received previously such as pain medication, androgen receptor pathway inhibitor, androgen deprivation therapy, chronic oral corticosteroid use, non-steroidal anti-androgen, radiotherapy, olaparib, prostatectomy and chemotherapy in the baseline period were reported in this outcome measure. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis. One participant could have received more than 1 treatment.

  Baseline period = Up to 1 year prior to index date; available data observed retrospectively over 178 days in this study

• Number of Participants According to Metastasis Status

  Number of participants according to metastasis status (metastatic prostate cancer and non-metastatic prostate cancer) were reported in this outcome measure. Metastatic prostate cancer was defined as having evidence of during the baseline period or within 90 days after the index date. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.

  Baseline period = Up to 1 year prior to index date or within 90 days after the index date; available data observed retrospectively over 178 days in this study

• Number of Participants According to Site of Metastasis

  Number of participants with a metastatic diagnosis at the sites: bone only, node only, bone and node, viscera and other (urinary organs, genital organs, skin, kidney, adrenal, brain, spinal, and other nervous system), were reported among participants with metastatic prostate cancer. Metastatic prostate cancer was defined as having evidence of metastasis any time prior to the index date or within 90 days after the index date. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.

  Baseline period = Up to 1 year prior to index date or within 90 days after the index date; available data observed retrospectively over 178 days in this study

• Number of Participants According to Androgen Deprivation Therapy (ADT) Status

  ADT naïve was defined as having no records of any systemic ADT ever based on all available data prior to the index date (i.e., including baseline period data and any available data prior to the baseline period). Systemic ADT included luteinizing hormone-releasing hormone (LHRH) agonists and gonadotropin-releasing hormone (GnRH) antagonists (i.e., degarelix, relugolix, goserelin, histrelin, leuprolide, triptorelin). ADT experienced was defined as having any records of systemic ADT based on all available data prior to the index date (i.e., including baseline period data and any available data prior to the baseline period). Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.

  Any time prior to index date including baseline period (approximately maximum up to 18 years); available data observed retrospectively over 178 days in this study

• Prostate-Specific Antigen (PSA) Value at 180 Days Prior to Index Date

  The index date was defined as the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed PC diagnosis.

  180 days prior to Index date; data observed retrospectively over 178 days in this study

• Testosterone Value at 180 Days Prior to Index Date

  The index date was defined as the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed PC diagnosis.

  180 days prior to Index date; data observed retrospectively over 178 days in this study

• Mean National Cancer Institute (NCI) Charlson Comorbidity Index (CCI) Score

  CCI based on various comorbid conditions such as myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic obstructive pulmonary disease, rheumatologic disease, peptic ulcer disease, mild liver disease, diabetes (mild to moderate), diabetes + complications, hemiplegia or paraplegia, renal disease, any malignancy (lymphoma and leukemia), moderate/severe liver disease, metastatic solid tumor, and acquired immune deficiency syndrome (AIDS) were reported. CCI score range was from 0 to 14, where "0"= low comorbid condition and "14"= high comorbid condition, higher scores indicated more comorbidity. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis.

  Baseline period = Up to 1 year prior to index date or within 90 days after the index date; available data observed retrospectively over 178 days in this study

• Number of Participants According to Comorbidities

  Number of participants according to comorbidities (hypertension, hyperlipidemia, diabetes, major adverse cardiovascular event, depression, congestive heart failure, sexual dysfunction, chronic obstructive pulmonary disease, anxiety, cognitive impairment, urinary tract infection, myocardial infarction, arrhythmia, stroke, acute coronary syndrome, angina pectoris, inflammatory bowel disease, hot flashes) were reported in this outcome measure. Baseline period was 1 year prior to index date; index date was the initiation date of relugolix (anytime between 18-Dec-2020 to 31-Dec-2023) on or after the first observed prostate cancer diagnosis. One participant could have more than one comorbidity.

  Baseline period = Up to 1 year prior to index date or within 90 days after the index date; available data observed retrospectively over 178 days in this study

Study Arms (1)

Relugolix patients

Patients who have initiated relugolix

Drug: Relugolix

Interventions

Relugolix DRUG

relugolix

Relugolix patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male patients with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men who are part of this study initiated relugolix as part of their usual treatment for PC

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10001, United States

Location

Related Publications (1)

• Freedland SJ, Ramaswamy K, Kavati A, Gao W, Razo JF, Cole M, Li B, Yang H, Guo T, Chen G, McKay RR. Retrospective Analysis of Racial Differences in Treatment Patterns and Prostate-Specific Antigen Responses Among Patients with Prostate Cancer Treated with Relugolix in the Veterans Health Administration. Adv Ther. 2025 Dec;42(12):6278-6294. doi: 10.1007/s12325-025-03390-6. Epub 2025 Nov 1.

  PMID: 41174189 DERIVED

Related Links

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

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

relugolix

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov.Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 17, 2024
• Study Start: June 19, 2024
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: December 11, 2025
• Results First Posted: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)