Trial record 1 of 7 for:
orgovyx
A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX (OPTYX)
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| ClinicalTrials.gov Identifier: NCT05467176 |
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Recruitment Status :
Recruiting
First Posted : July 20, 2022
Last Update Posted : March 16, 2023
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Sponsor:
Myovant Sciences GmbH
Information provided by (Responsible Party):
Myovant Sciences GmbH
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Brief 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Prostate Cancer | Drug: Relugolix |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX |
| Actual Study Start Date : | October 4, 2022 |
| Estimated Primary Completion Date : | May 31, 2028 |
| Estimated Study Completion Date : | May 31, 2028 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
MedlinePlus related topics:
Prostate Cancer
Drug Information available for:
Relugolix
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Drug: Relugolix
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:
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Primary Outcome Measures :
- Demographics [ Time Frame: Up to 5 years ]Patient demographics
- 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.
- 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)
- Clinical Characteristics [ Time Frame: Up to 5 years ]Clinical characteristics of patients
Secondary Outcome Measures :
- Clinical Course and Disease Progression [ Time Frame: Up to 5 years ]Changes in disease stage and clinical treatment
- Mortality [ Time Frame: Up to 5 years ]Any deaths that occur during the study
- Co-Morbidities [ Time Frame: Up to 5 years ]Changes in co-morbidities (presence and/or severity) as assessed by patient's physician
- Treatment Adherence [ Time Frame: Up to 5 years ]Describe patient adherence and persistence including reasons for change with ORGOVYX treatment
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05467176
Contacts
| Contact: Clinical Trials at Myovant | 650-278-8743 | ClinicalTrials@Myovant.com |
Locations
Show 25 study locations
Sponsors and Collaborators
Myovant Sciences GmbH
Investigators
| Study Director: | Myovant Medical Monitor | Myovant Sciences |
| Responsible Party: | Myovant Sciences GmbH |
| ClinicalTrials.gov Identifier: | NCT05467176 |
| Other Study ID Numbers: |
MVT-601-058 |
| First Posted: | July 20, 2022 Key Record Dates |
| Last Update Posted: | March 16, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by Myovant Sciences GmbH:
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relugolix ORGOVYX prostate cancer OPTYX |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases |
Relugolix Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |