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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients who are diagnosed with prostate cancer and initiating treatment with ORGOVYX at the time of enrollment or within 1 month prior to enrollment and who remain on treatment at enrollment - Patients who are willing and able to complete PRO assessments during the study - Patients who have reviewed and signed the informed consent form (ICF)

Exclusion Criteria

  • Patients with a history of surgical castration - Patients with a medical or psychiatric condition that precludes participation in the opinion of the treating physician - Patients whose original treatment plan is intended to be less than a total of 4 months of ORGOVYX

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Participants with Prostate Cancer Patients with prostate cancer who are initiating treatment or have initiated treatment with ORGOVYX (per label instructions) within 1 month prior to enrollment and who remain on treatment at the time of enrollment.
  • 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
    Other names:
    • TAK-385
    • MVT-601
    • RVT-601
    • T-1331285
    • ORGOVYX

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
Sumitomo Pharma Switzerland GmbH

Study Contact

Clinical Trials at Myovant
650-278-8743
ClinicalTrials@Myovant.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.