Clinical trial NCT05467176: A Multi-Center, Prospective, Observational Study of Patients Being Treated with ORGOVYX
Official title: A Multi-Center, Prospective, Observational Study of Patients Being Treated with ORGOVYX
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Keywords: relugolix
ORGOVYX
prostate cancer
OPTYX
Lead sponsor: Sumitomo Pharma Switzerland GmbH
Sponsor class: INDUSTRY
First posted: 2022-07-20
Enrollment: 999
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with prostate cancer who are initiating treatment or have initiated treatment with ORGOVYX within 1 month prior to enrollment and who remain on treatment at the time of enrollment

Brief 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.

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

Primary outcomes:
measure: Demographics
timeFrame: Up to 5 years
measure: Selective Safety Data
timeFrame: Up to 5 years
measure: Health-Related Quality-of-Life Indicators
timeFrame: Up to 5 years
measure: Clinical Characteristics
timeFrame: Up to 5 years
Secondary outcomes:
measure: Clinical Course and Disease Progression
timeFrame: Up to 5 years
measure: Mortality
timeFrame: Up to 5 years
measure: Co-Morbidities
timeFrame: Up to 5 years
measure: Treatment Adherence
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Mobile
country: United States
facility: Urology Associates of Mobile
state: Alabama
city: Phoenix
country: United States
facility: Dignity Health
state: Arizona
city: Tucson
country: United States
facility: Arizona Urology Specialists, PLLC
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Urology Research Center
state: Arkansas
city: Duarte
country: United States
facility: City of Hope
state: California
city: Fresno
country: United States
facility: Urology Associates of Central California
state: California
city: La Jolla
country: United States
facility: UCSD
state: California
city: Los Angeles
country: United States
facility: USC Norris Cancer Center
state: California
city: Los Angeles
country: United States
facility: Tower Urology
state: California
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Medical Center
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology
state: California
city: San Diego
country: United States
facility: Genesis Research LLC
state: California
city: Stockton
country: United States
facility: Golden State Urology
state: California
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center
state: Colorado
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Greeley
country: United States
facility: Banner MD Anderson Cancer Center
state: Colorado
city: Lakewood
country: United States
facility: Colorado Urology
state: Colorado
city: Lone Tree
country: United States
facility: Urology Associates
state: Colorado
city: Stamford
country: United States
facility: The Stamford Hospital
state: Connecticut
city: Washington, D.C.
country: United States
facility: Urologic Surgeons of Washington
state: District of Columbia
city: Washington
country: United States
facility: MemorialCare, Long Beach Memorial Medical Center
state: District of Columbia
city: Bay Pines
country: United States
facility: Bay Pines VA Healthcare System
state: Florida
city: Bradenton
country: United States
facility: Manatee Medical Research Institute, LLC
state: Florida
city: Daytona Beach
country: United States
facility: Advanced Urology Institute
state: Florida
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Miami
country: United States
facility: United Medical Group
state: Florida
city: Miami
country: United States
facility: SG Research LLC
state: Florida
city: Naples
country: United States
facility: Genesis Care USA
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners, LLP
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Decatur
country: United States
facility: Georgia Urology
state: Georgia
city: Arlington Heights
country: United States
facility: PRiSMS Group LLC
state: Illinois
city: Chicago Ridge
country: United States
facility: Associated Urological Specialists
state: Illinois
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Glenview
country: United States
facility: UroPartners Research
state: Illinois
city: Lake Barrington
country: United States
facility: Comprehensive Urologic Care
state: Illinois
city: Lisle
country: United States
facility: Duly Health and Care
state: Illinois
city: New Lenox
country: United States
facility: Advanced Urology Associates
state: Illinois
city: Carmel
country: United States
facility: Urology of Indiana
state: Indiana
city: Merrillville
country: United States
facility: Urologic Specialists of Northwest Indiana
state: Indiana
city: Creston
country: United States
facility: Greater Regional Health
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Wichita
country: United States
facility: Wichita Urology Group, P.A.
state: Kansas
city: Lexington
country: United States
facility: Baptists Health Lexington
state: Kentucky
city: Lafayette
country: United States
facility: Southern Urology
state: Louisiana
city: Baltimore
country: United States
facility: John Hopkins
state: Maryland
city: Baltimore
country: United States
facility: Chesapeake Urology Associates
state: Maryland
city: Columbia
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: Columbia
country: United States
facility: Medstar Georgetown University Hospital
state: Maryland
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Troy
country: United States
facility: GenesisCare USA
state: Michigan
city: Woodbury
country: United States
facility: Minnesota Urology
state: Minnesota
city: Saint Louis
country: United States
facility: Specialty Clinical Research of St. Louis
state: Missouri
city: Berkeley Heights
country: United States
facility: Summit Medical Group, P.A. | New Jersey Urology
state: New Jersey
city: Egg Harbor Township
country: United States
facility: AtlanticCare Cancer Institute
state: New Jersey
city: Paramus
country: United States
facility: The Valley Hospital
state: New Jersey
city: Teaneck
country: United States
facility: Regional Cancer Care Associates
state: New Jersey
city: Middletown
country: United States
facility: Crystal Run Healthcare
state: New York
city: Mount Kisco
country: United States
facility: Optum Medical Care, P. C.
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical Institution
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY, PLLC
state: New York
city: Utica
country: United States
facility: Mohawk Valley Health Services
state: New York
city: Charlotte
country: United States
facility: DJL Clinical Research, PLLC
state: North Carolina
city: Durham
country: United States
facility: Durham VA Healthcare
state: North Carolina
city: Greenville
country: United States
facility: GenesisCare USA
state: North Carolina
city: Raleigh
country: United States
facility: Associated Urologist of North Carolina
state: North Carolina
city: Beavercreek
country: United States
facility: Clinical Inquest Center Ltd
state: Ohio
city: Boardman
country: United States
facility: NEO Urology Associates, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Gahanna
country: United States
facility: Central Ohio Urology Group
state: Ohio
city: Springboro
country: United States
facility: Premier Clinical Research LLC dba STAT Research
state: Ohio
city: Toledo
country: United States
facility: The University of Toledo
state: Ohio
city: Springfield
country: United States
facility: Oregon Urology Institute
state: Oregon
city: Easton
country: United States
facility: Spokenword Clinical Trials
state: Pennsylvania
city: Lancaster
country: United States
facility: Keystone Urology Specialist
state: Pennsylvania
city: Latrobe
country: United States
facility: GU, Inc.
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center, LLC
state: South Carolina
city: North Charleston
country: United States
facility: Lowcountry Urology Clinics
state: South Carolina
city: Germantown
country: United States
facility: The Conrad Pearson Clinic
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Austin
country: United States
facility: Urology Austin
state: Texas
city: Houston
country: United States
facility: Hmu, Crc Llc
state: Texas
city: Houston
country: United States
facility: MD Anderson
state: Texas
city: Houston
country: United States
facility: New Horizon Medical Group, LLC
state: Texas
city: Houston
country: United States
facility: Ascend Pharma Holdings
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio, P.A. dba USA Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: The Urology Place
state: Texas
city: Alexandria
country: United States
facility: Potomac Urology Center, PC
state: Virginia
city: Richmond
country: United States
facility: MedAtlantic
state: Virginia
city: Virginia Beach
country: United States
facility: Urology of Virginia, PLLC
state: Virginia
city: Spokane
country: United States
facility: Spokane Urology, P.S.
state: Washington
city: Neenah
country: United States
facility: Wisconsin Institute of Urology
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus
state: Wisconsin
Study officials:
affiliation: Sumitomo Pharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: