Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

Reproductive Control Agents

All Drugs and Chemicals

Herbal and Botanical

Leuprolide

Relugolix

Antineoplastic Agents, Hormonal

Androgens

Androgen Antagonists

Hormones

Hormone Antagonists

Mace

Nutmeg

Oral relugolix 120 mg once daily with a loading dose of 360 mg on Day 1

Subcutaneous or intramuscular leuprolide acetate 22.5 mg 3-M depot or 45 mg 6-M injection or Leuprolide acetate injectable emulsion (42 mg injectable emulsion is not allowed)

Leuprolide Acetate

This was a randomized study to evaluate the risk of major adverse cardiovascular events (MACE) for relugolix compared with leuprolide acetate. Enrollment in this study was discontinued by the Sponsor on 01 Dec 2023. In an effort to mitigate any treatment interruptions, actively enrolled patients will be allowed to remain on study drug up to a period of 12 months ending Dec 2024 if they choose to remain in the discontinuation phase of the study.

Eligible patients were randomized (1:1) to receive either relugolix or leuprolide acetate for prostate cancer or as an adjunct to primary or salvage radiation therapy. The study was intended to collect clinical and cardiovascular risk factor data on patients ages 18 and older who were receiving relugolix or leuprolide acetate for their prostate cancer or as adjunct to radiation therapy with a treatment plan to be on at least 12 months of continuous ADT. Enrollment in this study was discontinued by the Sponsor on 04 Dec 2023. In an effort to mitigate any treatment interruptions, actively enrolled patients will be allowed to remain on study drug up to a period of 12 months ending Dec 2024. During this discontinuation phase, all active investigative sites will be expected to formulate a transition plan for their study patients from this clinical study to SOC as soon as practicable.

The primary endpoint in this study was the time to first adjudicated MACE (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death). However, with the discontinuation of enrollment in the study on 04 DEC 2023 by the sponsor, the primary endpoint will be to describe the safety of relugolix in the study population while actively enrolled patients remain on study drug.

Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate

Relugolix Versus Leuprolide in Patients With Prostate Cancer: A Randomized, Open-Label Study to Assess Major Adverse Cardiovascular Events (REPLACE-CV)

Incidence of selective safety data including all serious adverse events, nonserious adverse events leading to discontinuation of relugolix or leuprolide acetate, and clinical laboratory tests as obtained per standard of care

Sumitomo Pharma Switzerland GmbH

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.

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

Clinical Trials at Myovant

Myovant Medical Monitor

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.

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.

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

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

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

Changes in disease stage and clinical treatment

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate	NCT05605964	Prostate Cancer	Relugolix Leuprolide Acet...	18 Years -	Sumitomo Pharma Switzerland GmbH
A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX	NCT05467176	Prostate Cancer	Relugolix	18 Years -	Sumitomo Pharma Switzerland GmbH

Spots Global Cancer Trial Database for orgovyx

Every month we try and update this database with for orgovyx cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for orgovyx

Every month we try and update this database with for orgovyx cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for orgovyx cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.