Prostate Cancer Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

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 is for people with:

Prostate Cancer

Estimated Enrollment:

1000

Study ID:

NCT05467176

Recruitment Status:

Recruiting

Sponsor:

Myovant Sciences GmbH

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There are 10 Locations for this study

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The Stamford Hospital
Stamford Connecticut, 06902, United States
Manatee Medical Research Institute, LLC
Bradenton Florida, 34205, United States
PRiSMS Group LLC
Arlington Heights Illinois, 60005, United States
Comprehensive Urologic Care
Lake Barrington Illinois, 60010, United States
Urology of Indiana
Carmel Indiana, 46032, United States
DJL Clinical Research, PLLC
Charlotte North Carolina, 28210, United States
Clinical Inquest Center Ltd
Beavercreek Ohio, 45431, United States
The University of Toledo
Toledo Ohio, 43606, United States
Potomac Urology Center, PC
Alexandria Virginia, 22311, United States
Urology of Virginia, PLLC
Virginia Beach Virginia, 23462, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

1000

Study ID:

NCT05467176

Recruitment Status:

Recruiting

Sponsor:


Myovant Sciences GmbH

How clear is this clinincal trial information?

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