← Back to Search

Gonadotropin-Releasing Hormone (GnRH) Antagonist

ORGOVYX for Prostate Cancer (OPTYX Trial)

Verified Trial

N/A

Recruiting

Research Sponsored by Myovant Sciences GmbH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients 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

Be older than 18 years old

Must not have

Patients with a history of surgical castration

Patients whose original treatment plan is intended to be less than a total of 4 months of ORGOVYX

Timeline

Screening 3 days

Treatment Varies

Follow Up 3 days

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to gather real-world information on how safe and effective ORGOVYX is for patients with prostate cancer in regular clinical settings. It will also look at how patients respond to treatment with

Who is the study for?

This clinical trial is open to patients with prostate cancer who are starting treatment with ORGOVYX or have started within the past month and are still on it. Participants must be willing to complete patient-reported outcome assessments and sign an informed consent form.

What is being tested?

The study observes the real-world use of ORGOVYX in routine care for prostate cancer patients. It aims to gather data on its safety, effectiveness, and what happens during and after treatment.

What are the potential side effects?

While specific side effects aren't listed here, ORGOVYX may cause reactions typical of prostate cancer treatments such as hot flashes, fatigue, gastrointestinal issues, skin rash, or changes in liver function tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I started ORGOVYX for my prostate cancer up to 1 month before or at enrollment and am still on it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have undergone surgical castration.

Select...

My treatment plan with ORGOVYX is for less than 4 months.

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical Characteristics

Demographics

Health-Related Quality-of-Life Indicators

+1 more

Secondary study objectives

Clinical Course and Disease Progression

Co-Morbidities

Mortality

+1 more

Side effects data

From 2020 Phase 3 trial • 388 Patients • NCT03049735

11%

Hot flush

11%

Headache

Hypertension

Arthralgia

Upper respiratory tract infection

Avulsion fracture

Ankle fracture

Uterine myoma expulsion

Haematemesis

uterine leiomyoma

Menorrhagia

Pelvic pain

Rhabdomyolysis

Cough

Vitreous detachment

Hypothyroidism

100%

80%

60%

40%

20%

Study treatment Arm

Relugolix Plus E2/NETA (Group A)

Relugolix Plus Delayed E2/NETA (Group B)

Placebo (Group C)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with Prostate CancerExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Relugolix

2016

Completed Phase 3

~5410

0 / 3Eligibility criteria met