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

Clinicaltrials.gov ID: NCT05467176
db-list-check Status RECRUITING
b-loader Phase
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 1000

Conditions

Prostate Cancer

Drugs

Relugolix

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.

Locations

63 locations Found with status Recruiting

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

Status

  • RECRUITING

Central Contacts

Study Director

  • Myovant Medical Monitor

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

Study Plan

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.

  • DRUG:

    Relugolix

    Description:

    Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1

Outcome Measures

Primary Outcome Measures

Demographics

Time Frame: Up to 5 years

Selective Safety Data

Time Frame: Up to 5 years

Health-Related Quality-of-Life Indicators

Time Frame: Up to 5 years

Clinical Characteristics

Time Frame: Up to 5 years

Secondary Outcome Measures

Clinical Course and Disease Progression

Time Frame: Up to 5 years

Mortality

Time Frame: Up to 5 years

Co-Morbidities

Time Frame: Up to 5 years

Treatment Adherence

Time Frame: Up to 5 years

Timeline

  • Last Updated
    March 12, 2024
  • Start Date
    July 20, 2022
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    May 31, 2028

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