ORGOVYX for Prostate Cancer

(OPTYX Trial)

Recruiting at 101 trial locations

Overseen By Clinical Trials at Myovant

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Sumitomo Pharma Switzerland GmbH

Must be taking: Orgovyx

Disqualifiers: Surgical castration, Medical condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 5 years

999 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor to understand how ORGOVYX might interact with your existing treatments.

What data supports the effectiveness of the drug Relugolix (Orgovyx) for treating prostate cancer?

Relugolix (Orgovyx) is effective for treating advanced prostate cancer by rapidly reducing testosterone levels, which helps slow cancer growth. In a major study, it maintained testosterone suppression in over 90% of patients for 48 weeks and showed a lower risk of heart-related side effects compared to another common treatment, leuprolide. ^{1 2 3 4 5}

How does the drug ORGOVYX (Relugolix) differ from other prostate cancer treatments?

ORGOVYX (Relugolix) is unique because it is an oral medication that works by blocking the pituitary gland from producing hormones that stimulate the prostate cancer cells, unlike traditional treatments that often require injections or surgeries. ^{6 7 8 9 10}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with ORGOVYX and monitored for treatment patterns, adherence, and selective safety data

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including health outcomes and quality-of-life

Up to 5 years

Treatment Details

Interventions

• Relugolix

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 United States, Japan, European Union for the following indications:

Approved in United States as Orgovyx for:

• Advanced prostate cancer
• Uterine fibroids

Approved in Japan as Relumina for:

• Uterine fibroids

Approved in European Union as Orgovyx for:

• Advanced prostate cancer

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+

Findings from Research

Relugolix (Orgovyx) is the first oral medication approved for treating advanced prostate cancer, functioning as a gonadotropin-releasing hormone receptor antagonist.

While effective, relugolix carries risks such as prolonging the QT interval and potential embryo-fetal toxicity, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Oral Hormone for Treating Prostate Cancer. Aschenbrenner, DS.[2023]

In the phase III HERO trial, relugolix demonstrated a sustained castration rate of over 90% in men with advanced prostate cancer over 48 weeks, which was non-inferior to the traditional treatment with leuprolide, and showed potential superiority in exploratory analyses.

Relugolix is generally well tolerated and may have a lower risk of major adverse cardiac events compared to leuprolide, making it a promising oral treatment option for rapid testosterone suppression without the initial surge associated with other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relugolix: A Review in Advanced Prostate Cancer. Shirley, M.[2023]

In a phase 3 study involving 934 men with advanced prostate cancer, relugolix, an oral medication, showed similar health-related quality of life (HRQOL) outcomes compared to leuprolide, an injectable treatment, during the treatment phase.

During the testosterone recovery phase, patients on relugolix reported fewer hormone-related symptoms than those on leuprolide, indicating that relugolix may offer a more favorable side effect profile and quicker testosterone recovery after treatment cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Relugolix Versus Leuprolide on the Quality of Life of Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study. Tombal, B., Collins, S., Morgans, AK., et al.[2023]

In a study of 91 patients prescribed relugolix for prostate cancer, 78% filled their prescriptions, and 93% reported never missing a dose, indicating good compliance with the oral medication.

No major safety concerns were identified, even when relugolix was used in combination with other therapies, and most patients who switched from other androgen deprivation therapies reported similar or improved tolerance with relugolix.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Practical Guide to Relugolix: Early Experience With Oral Androgen Deprivation Therapy. Kasparian, S., Wei, O., Tsai, NC., et al.[2023]

This systematic review analyzed 24 prostate cancer patients and found that immunotherapies, particularly IMM-101, showed promising results with a mean overall survival (OS) of 56 months, indicating potential benefits for patients.

Among the immunotherapies studied, Pembrolizumab and IMM-101 were the most commonly used, highlighting their relevance in the treatment landscape for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Has the Landscape of Immunotherapy for Prostate Cancer Changed? A Systematic Review and Post Hoc Analysis. Ashraf, MU., Farwa, U., Siddiqa, M., et al.[2023]

Immunotherapy, particularly using the MVA-5T4 (TroVax(®)) vaccine, shows potential as a treatment for advanced castration-resistant prostate cancer, leveraging prostate-associated antigens for targeted therapy.

Preclinical studies and limited clinical trials indicate that the MVA-5T4 vaccine has demonstrated promise in treating prostate cancer, similar to its effectiveness observed in colorectal and renal cell carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on TroVax for the treatment of progressive castration-resistant prostate cancer. Abern, M., Kaufman, HL., Latchamsetty, K.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

First Oral Hormone for Treating Prostate Cancer. [2023]

2. France pubmed.ncbi.nlm.nih.gov

Relugolix: A Review in Advanced Prostate Cancer. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Relugolix Versus Leuprolide on the Quality of Life of Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of Concomitant Prostate Cancer Medications on Efficacy and Safety of Relugolix Versus Leuprolide in Men With Advanced Prostate Cancer. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A Practical Guide to Relugolix: Early Experience With Oral Androgen Deprivation Therapy. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Oncoxin-Viusid® may improve quality of life and survival in patients with hormone-refractory prostate cancer undergoing onco-specific treatments. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Reovirus mutant jin-3 exhibits lytic and immune-stimulatory effects in preclinical human prostate cancer models. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Oncolytic virus-initiated protective immunity against prostate cancer. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Has the Landscape of Immunotherapy for Prostate Cancer Changed? A Systematic Review and Post Hoc Analysis. [2023]

10. New Zealand pubmed.ncbi.nlm.nih.gov

An update on TroVax for the treatment of progressive castration-resistant prostate cancer. [2021]