NCT05467176

A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 999 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, prospective, observational study of patients being treated with ORGOVYX. The goal of this study is to generate real-world evidence about the safety and effectiveness of ORGOVYX in patients with prostate cancer in routine clinical care and the clinical course during treatment with and following cessation of ORGOVYX.

Detailed description

This prospective observational cohort study will be conducted in patients who are initiating treatment or have initiated treatment with ORGOVYX within the 1 month prior to the time of study enrollment and who remain on treatment at the time of enrollment. The decision to initiate treatment with ORGOVYX should be made prior to study enrollment. The study is designed to better understand the actual experience of patients with prostate cancer treated with ORGOVYX by collecting data on treatment patterns, adherence, and selective safety data. Additionally, a better understanding of the trajectory of patients with prostate cancer following cessation of ORGOVYX therapy will be gained by observing the clinical course of the disease, health outcomes, and health-related quality-of-life (HRQoL) in these patients.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Relugolix	Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1

Timeline

• Start date: 2022-10-04
• Primary completion: 2026-06-30
• Completion: 2026-07-30
• First posted: 2022-07-20
• Last updated: 2026-04-08

Locations

96 sites across 1 country: United States

Regulatory

• FDA-regulated drug study