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

Prostate Cancer Clinical Trial

— OPTYX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05467176
• Other study ID #: MVT-601-058
• Status: Recruiting
• Start date: October 4, 2022
• Est. completion date: May 31, 2028

Study information

• Verified date: March 2024
• Source: Sumitomo Pharma Switzerland GmbH
• Contact: Clinical Trials at Myovant
• Phone: 650-278-8743
• Email: ClinicalTrials[@]Myovant.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: May 31, 2028
• Est. primary completion date: May 31, 2028
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Potomac Urology Center, PC	Alexandria	Virginia
United States	PRiSMS Group LLC	Arlington Heights	Illinois
United States	Rocky Mountain Regional VA Medical Center	Aurora	Colorado
United States	Urology Austin	Austin	Texas
United States	Chesapeake Urology Associates	Baltimore	Maryland
United States	Clinical Inquest Center Ltd	Beavercreek	Ohio
United States	Summit Health | New Jersey Urology	Berkeley Heights	New Jersey
United States	NEO Urology Associates, Inc.	Boardman	Ohio
United States	Manatee Medical Research Institute, LLC	Bradenton	Florida
United States	Urology of Indiana	Carmel	Indiana
United States	DJL Clinical Research, PLLC	Charlotte	North Carolina
United States	Associated Urological Specialists	Chicago Ridge	Illinois
United States	University Hospitals	Cleveland	Ohio
United States	Advanced Urology Institute	Daytona Beach	Florida
United States	The Urology Center of Colorado	Denver	Colorado
United States	AtlanticCare Cancer Institute	Egg Harbor Township	New Jersey
United States	Northwestern University	Evanston	Illinois
United States	Urology Associates of Central California	Fresno	California
United States	Central Ohio Urology Group	Gahanna	Ohio
United States	The Conrad Pearson Clinic	Germantown	Tennessee
United States	UroPartners Research	Glenview	Illinois
United States	Memorial Healthcare System	Hollywood	Florida
United States	Urology Centers of Alabama	Homewood	Alabama
United States	Hmu, Crc Llc	Houston	Texas
United States	New Horizon Medical Group, LLC	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Southern Urology	Lafayette	Louisiana
United States	Comprehensive Urologic Care	Lake Barrington	Illinois
United States	Keystone Urology Specialist	Lancaster	Pennsylvania
United States	GU, Inc.	Latrobe	Pennsylvania
United States	Arkansas Urology Research Center	Little Rock	Arkansas
United States	Urology Associates	Lone Tree	Colorado
United States	Tower Urology	Los Angeles	California
United States	Urologic Specialists of Northwest Indiana	Merrillville	Indiana
United States	SG Research LLC	Miami	Florida
United States	Crystal Run Healthcare	Middletown	New York
United States	Urology Associates of Mobile	Mobile	Alabama
United States	Urologic Surgeons of Long Island	Mount Kisco	New York
United States	Tri Valley Urology	Murrieta	California
United States	Carolina Urologic Research Center, LLC	Myrtle Beach	South Carolina
United States	Wisconsin Institute of Urology	Neenah	Wisconsin
United States	Advanced Urology Associates	New Lenox	Illinois
United States	Lowcountry Urology Clinics	North Charleston	South Carolina
United States	The Valley Hospital	Paramus	New Jersey
United States	Dignity Health	Phoenix	Arizona
United States	Associated Urologist of North Carolina	Raleigh	North Carolina
United States	MedAtlantic	Richmond	Virginia
United States	Specialty Clinical Research of St. Louis	Saint Louis	Missouri
United States	The Urology Place	San Antonio	Texas
United States	Urology San Antonio	San Antonio	Texas
United States	Genesis Research LLC	San Diego	California
United States	Spokane Urology, P.S.	Spokane	Washington
United States	Premier Clinical Research LLC dba STAT Research	Springboro	Ohio
United States	The Stamford Hospital	Stamford	Connecticut
United States	Associated Medical Professionals of NY, PLLC	Syracuse	New York
United States	Florida Urology Partners, LLP	Tampa	Florida
United States	Regional Cancer Care Associates	Teaneck	New Jersey
United States	The University of Toledo	Toledo	Ohio
United States	Arizona Urology Specialists, PLLC	Tucson	Arizona
United States	Urology of Virginia, PLLC	Virginia Beach	Virginia
United States	Urologic Surgeons of Washington	Washington	District of Columbia
United States	Wichita Urology Group, P.A.	Wichita	Kansas
United States	Minnesota Urology	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma Switzerland GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographics	Patient demographics	Up to 5 years
Primary	Selective Safety Data	Incidence of treatment-related serious adverse events and any adverse events resulting in discontinuation of ORGOVYX as reported by physician or patient.	Up to 5 years
Primary	Health-Related Quality-of-Life Indicators	Changes to health-related quality-of-life indicators as measured by patient-reported outcomes (PROs)	Up to 5 years
Primary	Clinical Characteristics	Clinical characteristics of patients	Up to 5 years
Secondary	Clinical Course and Disease Progression	Changes in disease stage and clinical treatment	Up to 5 years
Secondary	Mortality	Any deaths that occur during the study	Up to 5 years
Secondary	Co-Morbidities	Changes in co-morbidities (presence and/or severity) as assessed by patient's physician	Up to 5 years
Secondary	Treatment Adherence	Describe patient adherence and persistence including reasons for change with ORGOVYX treatment	Up to 5 years