ORGOVYX for Prostate Cancer

(OPTYX Trial)

Recruiting at 101 trial locations

Overseen By Clinical Trials at Myovant

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sumitomo Pharma Switzerland GmbH

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Medical Monitor

Principal Investigator

Sumitomo Pharma

Eligibility Criteria

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.

Inclusion Criteria

Patients who have reviewed and signed the informed consent form (ICF)

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

Patients willing and able to complete PRO assessments during the study

Exclusion Criteria

Patients with a medical or psychiatric condition that precludes participation in the opinion of the treating physician

I have undergone surgical castration.

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

Treatment Details

Interventions

• Relugolix (Gonadotropin-Releasing Hormone (GnRH) Antagonist)

Trial Overview 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.

Participant Groups

Group I: Participants with Prostate Cancer Experimental Treatment 1 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.

Relugolix is already approved in Japan for the following indications:

Approved in Japan as Relumina for:

• Uterine fibroids

Who Is Running the Clinical Trial?

Sumitomo Pharma Switzerland GmbH

Lead Sponsor

Trials

19

Recruited

6,900+

Myovant Sciences GmbH

Lead Sponsor

Trials

23

Recruited

12,500+