A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX
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.
Conditions:
🦠 Prostate Cancer
🗓️ Study Start (Actual) 4 October 2022
🗓️ Primary Completion (Estimated) 31 May 2028
✅ Study Completion (Estimated) 31 May 2028
👥 Enrollment (Estimated) 1000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Homewood, Alabama, United States
📍 Mobile, Alabama, United States
📍 Phoenix, Arizona, United States
📍 Tucson, Arizona, United States
📍 Little Rock, Arkansas, United States
📍 Fresno, California, United States
📍 Los Angeles, California, United States
📍 Murrieta, California, United States
📍 San Diego, California, United States
📍 Aurora, Colorado, United States
📍 Denver, Colorado, United States
📍 Lone Tree, Colorado, United States
📍 Stamford, Connecticut, United States
📍 Washington, District of Columbia, United States
📍 Bradenton, Florida, United States
📍 Daytona Beach, Florida, United States
📍 Hollywood, Florida, United States
📍 Miami, Florida, United States
📍 Tampa, Florida, United States
📍 Arlington Heights, Illinois, United States
📍 Chicago Ridge, Illinois, United States
📍 Evanston, Illinois, United States
📍 Glenview, Illinois, United States
📍 Lake Barrington, Illinois, United States
📍 New Lenox, Illinois, United States
📍 Carmel, Indiana, United States
📍 Merrillville, Indiana, United States
📍 Kansas City, Kansas, United States
📍 Wichita, Kansas, United States
📍 Lafayette, Louisiana, United States
📍 Baltimore, Maryland, United States
📍 Woodbury, Minnesota, United States
📍 Saint Louis, Missouri, United States
📍 Berkeley Heights, New Jersey, United States
📍 Egg Harbor Township, New Jersey, United States
📍 Paramus, New Jersey, United States
📍 Teaneck, New Jersey, United States
📍 Middletown, New York, United States
📍 Mount Kisco, New York, United States
📍 Syracuse, New York, United States
📍 Charlotte, North Carolina, United States
📍 Raleigh, North Carolina, United States
📍 Beavercreek, Ohio, United States
📍 Boardman, Ohio, United States
📍 Cleveland, Ohio, United States
📍 Gahanna, Ohio, United States
📍 Springboro, Ohio, United States
📍 Toledo, Ohio, United States
📍 Lancaster, Pennsylvania, United States
📍 Latrobe, Pennsylvania, United States
📍 Myrtle Beach, South Carolina, United States
📍 North Charleston, South Carolina, United States
📍 Germantown, Tennessee, United States
📍 Austin, Texas, United States
📍 Houston, Texas, United States
📍 Houston, Texas, United States
📍 San Antonio, Texas, United States
📍 San Antonio, Texas, United States
📍 Alexandria, Virginia, United States
📍 Richmond, Virginia, United States
📍 Virginia Beach, Virginia, United States
📍 Spokane, Washington, United States
📍 Neenah, Wisconsin, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 June 2022
  • First Submitted that Met QC Criteria 18 July 2022
  • First Posted 20 July 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 March 2024
  • Last Update Posted 12 March 2024
  • Last Verified March 2024