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

NCT ID: NCT06462014

Last Updated: 2025-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

507 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-19

Study Completion Date

2024-12-13

Brief Summary

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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

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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.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Relugolix patients

Patients who have initiated relugolix

Relugolix

Intervention Type DRUG

relugolix

Interventions

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Relugolix

relugolix

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 41174189 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C4751009

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

Other Identifiers

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VHA Study

Identifier Type: OTHER

Identifier Source: secondary_id

C4751009

Identifier Type: -

Identifier Source: org_study_id

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