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

Study Identifier:
MVT-601-058
CT.gov Identifier:
NCT05467176
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study Summary

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.

To prospectively understand the actual experience of patients with prostate cancer treated with relugolix through data collection on patients selected for treatment, treatment patterns, adherence, patient reported quality of life (QoL) and safety data.

To collect evidence on the long-term safety, effectiveness, treatment patterns, disease course, and patient outcomes with relugolix in real-world care.

Data collected included baseline demographics, clinical characteristics, reasons for initiating treatment, treatment patterns, and quality of life (FACT-P) questionnaires

To assess adherence using the Simplified Medication Adherence Questionnaire (SMAQ) and T suppression in clinical practice. Data on treatment patterns, clinical, safety, and patient-reported outcomes are being collected. Adherence is being assessed using the pt-reported SMAQ and T levels are being collected as part of routine care. Analyses of adherence and T levels were conducted independently.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Prostate
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    IV
    Sex
    Male
    Age
    18+ years
    Study Drug
  • Drug: Participants with Prostate Cancer
    • Read More
  • Drug: Drug: Relugolix
  • Drug: Patients will be followed for up to 5 years.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    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)
    • study population includes diverse disease states, treatment circumstances (eg, monotherapy, combination therapy, or intermittent therapy) and clinical settings representative of real-world patterns of care.
    • ASCO 2025:
    • PC patients (pts) who initiated relugolix within 1 month prior to enrollment were enrolled from US clinical sites into OPTYX
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Prostate