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OpenTrials
Completed

NCT Number: NCT05467176

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Urology Centers of Alabama, Homewood, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: TAK-385, MVT-601, RVT-601, T-1331285, ORGOVYX

Primary outcomes

  1. Demographics

    Time frame: Up to 5 years

    Patient demographics

  2. Selective Safety Data

    Time frame: Up to 5 years

    Incidence of treatment-related serious adverse events and any adverse events resulting in discontinuation of ORGOVYX as reported by physician or patient.

  3. Health-Related Quality-of-Life Indicators

    Time frame: Up to 5 years

    Changes to health-related quality-of-life indicators as measured by patient-reported outcomes (PROs)

  4. Clinical Characteristics

    Time frame: Up to 5 years

    Clinical characteristics of patients

Secondary outcomes

  1. Clinical Course and Disease Progression

    Time frame: Up to 5 years

    Changes in disease stage and clinical treatment

  2. Mortality

    Time frame: Up to 5 years

    Any deaths that occur during the study

  3. Co-Morbidities

    Time frame: Up to 5 years

    Changes in co-morbidities (presence and/or severity) as assessed by patient's physician

  4. Treatment Adherence

    Time frame: Up to 5 years

    Describe patient adherence and persistence including reasons for change with ORGOVYX treatment

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Acronym: OPTYX

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2022
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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