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Gonadotropin-Releasing Hormone (GnRH) Antagonist

Participants with Prostate Cancer 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
Timeline
Screening 3 days
Treatment Varies
Follow Up 3 days
Awards & highlights

OPTYX Trial 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.Check my eligibility
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.See study design
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.

OPTYX Trial 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.

OPTYX Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Characteristics
Demographics
Health-Related Quality-of-Life Indicators
+1 more
Secondary outcome measures
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
5%
Hypertension
3%
Arthralgia
1%
Upper respiratory tract infection
1%
Avulsion fracture
1%
Ankle fracture
1%
Uterine myoma expulsion
1%
Haematemesis
1%
uterine leiomyoma
1%
Menorrhagia
1%
Pelvic pain
1%
Rhabdomyolysis
1%
Cough
1%
Vitreous detachment
1%
Hypothyroidism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Relugolix Plus E2/NETA (Group A)
Relugolix Plus Delayed E2/NETA (Group B)
Placebo (Group C)

OPTYX 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
~5360

Find a Location

Who is running the clinical trial?

Myovant Sciences GmbHLead Sponsor
22 Previous Clinical Trials
11,490 Total Patients Enrolled
5 Trials studying Prostate Cancer
3,644 Patients Enrolled for Prostate Cancer
Myovant Medical MonitorStudy DirectorMyovant Sciences
9 Previous Clinical Trials
4,559 Total Patients Enrolled
1 Trials studying Prostate Cancer
1,134 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being enrolled in this research study at the moment?

"The clinical trial, as documented on clinicaltrials.gov, is actively seeking participants. The initial post was made on October 4th, 2022 and the latest update occurred on January 5th, 2024."

Answered by AI

What is the upper limit on the count of participants involved in this study?

"Affirmative. The information available on clinicaltrials.gov indicates that this particular trial is actively seeking eligible participants. Initially shared on October 4th, 2022, the last update was made on January 5th, 2024. The investigators aim to enroll a total of 1000 patients distributed across 64 different locations."

Answered by AI

What is the primary goal of conducting this clinical trial?

"As per the trial sponsor, Myovant Sciences GmbH, the primary focus of this investigation will be assessing Specific Safety Data over a period extending Up to 5 years. Additionally, secondary endpoints encompass evaluating Mortality (defined as Any deaths during the study), Co-Morbidities (interpreted as Alterations in co-existing conditions' presence and/or severity evaluated by patients’ healthcare providers), and Treatment Adherence (comprising an account of patient compliance and continuity with ORGOVYX therapy alongside rationales for modifications)."

Answered by AI

At how many distinct venues is this medical trial currently being conducted?

"The clinical investigation is being conducted at Associated Urological Specialists in Chicago Ridge, Illinois, Advanced Urology Institute in Daytona Beach, Florida, and UroPartners Research in Glenview, New jersey among an additional 64 sites."

Answered by AI

Who else is applying?

What site did they apply to?
Memorial Healthcare System
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

Necesito una cura para el cancer se prostata no un tratamiento como el que tengo en la actualidad.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX
2022. "A Multi-Center, Prospective, Observational Study of Patients Being Treated With ORGOVYX". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05467176.
All > Prostate Cancer High Point > Prostate Cancer
~667 spots leftby May 2028
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