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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relugolix | Drug | Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demographics | Patient demographics | Up to 5 years |
| 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 |
| 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 |
| Clinical Characteristics | Clinical characteristics of patients | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Course and Disease Progression | Changes in disease stage and clinical treatment | Up to 5 years |
| Mortality | Any deaths that occur during the study |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sumitomo Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Centers of Alabama | Homewood | Alabama | 35209 | United States | ||
| Urology Associates of Mobile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38488039 | Derived | Spratt DE, Dorff T, McKay RR, Lowentritt BH, Fallick M, Gatoulis SC, Flanders SC, Ross AE. Evaluating relugolix for the treatment of prostate cancer in real-world settings of care: the OPTYX study protocol. Future Oncol. 2024 Apr;20(12):727-738. doi: 10.2217/fon-2023-0748. Epub 2024 Mar 15. |
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|
| Up to 5 years |
| Co-Morbidities | Changes in co-morbidities (presence and/or severity) as assessed by patient's physician | Up to 5 years |
| Treatment Adherence | Describe patient adherence and persistence including reasons for change with ORGOVYX treatment | Up to 5 years |
| 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 |
| City of Hope | Duarte | California | 91010 | United States |
| Urology Associates of Central California | Fresno | California | 93720 | United States |
| UCSD | La Jolla | California | 92097 | United States |
| USC Norris Cancer Center | Los Angeles | California | 90033 | United States |
| Tower Urology | Los Angeles | California | 90048 | United States |
| VA Greater Los Angeles Medical Center | Los Angeles | California | 90073 | United States |
| Tri Valley Urology | Murrieta | California | 92562 | United States |
| Genesis Research LLC | San Diego | California | 92123 | United States |
| Golden State Urology | Stockton | California | 95219 | United States |
| Rocky Mountain Regional VA Medical Center | Aurora | Colorado | 80045 | United States |
| The Urology Center of Colorado | Denver | Colorado | 80211 | United States |
| Banner MD Anderson Cancer Center | Greeley | Colorado | 80631 | United States |
| Colorado Urology | Lakewood | Colorado | 80228 | United States |
| Urology Associates | Lone Tree | Colorado | 80124 | United States |
| The Stamford Hospital | Stamford | Connecticut | 06902 | United States |
| Urologic Surgeons of Washington | Washington D.C. | District of Columbia | 20036 | United States |
| MemorialCare, Long Beach Memorial Medical Center | Washington D.C. | District of Columbia | 20037 | United States |
| Bay Pines VA Healthcare System | Bay Pines | Florida | 33744 | 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 |
| United Medical Group | Miami | Florida | 33135 | United States |
| SG Research LLC | Miami | Florida | 33145 | United States |
| Genesis Care USA | Naples | Florida | 34119 | United States |
| Florida Urology Partners, LLP | Tampa | Florida | 33607 | United States |
| Emory University | Atlanta | Georgia | 30342 | United States |
| Georgia Urology | Decatur | Georgia | 30033 | 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 |
| Duly Health and Care | Lisle | Illinois | 60532 | 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 |
| Greater Regional Health | Creston | Iowa | 50801 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Wichita Urology Group, P.A. | Wichita | Kansas | 67226 | United States |
| Baptists Health Lexington | Lexington | Kentucky | 40503 | United States |
| Southern Urology | Lafayette | Louisiana | 70508 | United States |
| John Hopkins | Baltimore | Maryland | 20777 | United States |
| Chesapeake Urology Associates | Baltimore | Maryland | 21204 | United States |
| Maryland Oncology Hematology | Columbia | Maryland | 21044 | United States |
| Medstar Georgetown University Hospital | Columbia | Maryland | 21044 | United States |
| Michigan Institute of Urology | Troy | Michigan | 48084 | United States |
| GenesisCare USA | Troy | Michigan | 48098 | United States |
| Minnesota Urology | Woodbury | Minnesota | 55125 | United States |
| Specialty Clinical Research of St. Louis | St Louis | Missouri | 63141 | United States |
| Summit Medical Group, P.A. | New Jersey Urology | Berkeley Heights | New Jersey | 907922 | United States |
| AtlanticCare Cancer Institute | Egg Harbor | New Jersey | 08234 | United States |
| The Valley Hospital | Paramus | New Jersey | 07652 | United States |
| Regional Cancer Care Associates | Teaneck | New Jersey | 07666 | United States |
| Crystal Run Healthcare | Middletown | New York | 10941 | United States |
| Optum Medical Care, P. C. | Mount Kisco | New York | 10549 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| SUNY Upstate Medical Institution | Syracuse | New York | 13210 | United States |
| Associated Medical Professionals of NY, PLLC | Syracuse | New York | 95054 | United States |
| Mohawk Valley Health Services | Utica | New York | 13502 | United States |
| DJL Clinical Research, PLLC | Charlotte | North Carolina | 28210 | United States |
| Durham VA Healthcare | Durham | North Carolina | 27705 | United States |
| GenesisCare USA | Greenville | North Carolina | 27834 | 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 of Cincinnati Medical Center | Cincinnati | Ohio | 45267 | 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 |
| Oregon Urology Institute | Springfield | Oregon | 97477 | United States |
| Spokenword Clinical Trials | Easton | Pennsylvania | 18045 | 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 |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| Urology Austin | Austin | Texas | 78759 | United States |
| Hmu, Crc Llc | Houston | Texas | 77027 | United States |
| MD Anderson | Houston | Texas | 77030 | United States |
| New Horizon Medical Group, LLC | Houston | Texas | 77042 | United States |
| Ascend Pharma Holdings | Houston | Texas | 77079 | United States |
| Urology San Antonio, P.A. dba USA Clinical Trials | 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 |
| Wisconsin Institute of Urology | Neenah | Wisconsin | 54956 | United States |
| Aspirus | Wausau | Wisconsin | 54401 | United States |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C561634 | relugolix |
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