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.

View Eligibility Criteria

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 57 Locations for this study

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Urology Centers of Alabama
Homewood Alabama, 35209, United States
Urology Associates of Mobile
Mobile Alabama, 36607, United States
Dignity Health
Phoenix Arizona, 85013, United States
Arizona Urology Specialists, PLLC
Tucson Arizona, 85704, United States
Arkansas Urology Research Center
Little Rock Arkansas, 72211, United States
Urology Associates of Central California
Fresno California, 93720, United States
Tower Urology
Los Angeles California, 90048, United States
Rocky Mountain Regional VA Medical Center
Aurora Colorado, 80045, United States
The Urology Center of Colorado
Denver Colorado, 80211, United States
Urology Associates
Lone Tree Colorado, 80124, United States
The Stamford Hospital
Stamford Connecticut, 06902, United States
Urologic Surgeons of Washington
Washington District of Columbia, 20036, United States
Manatee Medical Research Institute, LLC
Bradenton Florida, 34205, United States
Advanced Urology Institute
Daytona Beach Florida, 32114, United States
Memorial Healthcare System
Hollywood Florida, 33021, United States
SG Research LLC
Miami Florida, 33145, United States
Florida Urology Partners, LLP
Tampa Florida, 33607, United States
PRiSMS Group LLC
Arlington Heights Illinois, 60005, United States
Associated Urological Specialists
Chicago Ridge Illinois, 60415, United States
Northwestern University
Evanston Illinois, 60208, United States
UroPartners Research
Glenview Illinois, 60026, United States
Comprehensive Urologic Care
Lake Barrington Illinois, 60010, United States
Advanced Urology Associates
New Lenox Illinois, 60451, United States
Urology of Indiana
Carmel Indiana, 46032, United States
Urologic Specialists of Northwest Indiana
Merrillville Indiana, 46410, United States
University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Wichita Urology Group, P.A.
Wichita Kansas, 67226, United States
Southern Urology
Lafayette Louisiana, 70508, United States
Chesapeake Urology Associates
Baltimore Maryland, 21204, United States
Minnesota Urology
Woodbury Minnesota, 55125, United States
Specialty Clinical Research of St. Louis
Saint Louis Missouri, 63141, United States
AtlanticCare Cancer Institute
Egg Harbor Township New Jersey, 08234, United States
Regional Cancer Care Associates
Teaneck New Jersey, 07666, United States
Crystal Run Healthcare
Middletown New York, 10941, United States
Associated Medical Professionals of NY, PLLC
Syracuse New York, 95054, United States
DJL Clinical Research, PLLC
Charlotte North Carolina, 28210, United States
Associated Urologist of North Carolina
Raleigh North Carolina, 27612, United States
Clinical Inquest Center Ltd
Beavercreek Ohio, 45431, United States
NEO Urology Associates, Inc.
Boardman Ohio, 44512, United States
University Hospitals
Cleveland Ohio, 44106, United States
Central Ohio Urology Group
Gahanna Ohio, 43230, United States
Premier Clinical Research LLC dba STAT Research
Springboro Ohio, 45440, United States
The University of Toledo
Toledo Ohio, 43606, United States
Keystone Urology Specialist
Lancaster Pennsylvania, 17604, United States
GU, Inc.
Latrobe Pennsylvania, 15650, United States
Carolina Urologic Research Center, LLC
Myrtle Beach South Carolina, 29572, United States
Lowcountry Urology Clinics
North Charleston South Carolina, 29406, United States
The Conrad Pearson Clinic
Germantown Tennessee, 38138, United States
Urology Austin
Austin Texas, 78759, United States
Hmu, Crc Llc
Houston Texas, 77027, United States
New Horizon Medical Group, LLC
Houston Texas, 77042, United States
Urology San Antonio
San Antonio Texas, 78229, United States
The Urology Place
San Antonio Texas, 78240, United States
Potomac Urology Center, PC
Alexandria Virginia, 22311, United States
MedAtlantic
Richmond Virginia, 23235, United States
Urology of Virginia, PLLC
Virginia Beach Virginia, 23462, United States
Spokane Urology, P.S.
Spokane Washington, 99202, United States

How clear is this clinincal trial information?

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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