ORGOVYX for Prostate Cancer

(OPTYX Trial)

Not currently recruiting at 105 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather real-world information on the safety and effectiveness of ORGOVYX (Relugolix) for treating prostate cancer. The focus is on understanding the treatment's impact during use and after discontinuation. Men with prostate cancer who have started or are about to start ORGOVYX treatment are suitable candidates for this study. Participants should be prepared to complete health questionnaires during the trial. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and proven effective treatment benefits more patients, providing valuable insights into its broader impact.

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 is the safety track record for ORGOVYX?

Research has shown that relugolix is generally well-tolerated by patients with prostate cancer. Studies have demonstrated its effectiveness in reducing testosterone levels, a crucial factor in treating prostate cancer. Importantly, these studies identified no new safety issues.

Another study found that most patients using relugolix adhered well to their medication schedule. There were no significant changes in lab tests, heart monitoring, or vital signs, indicating the treatment does not cause major side effects.

Overall, the evidence suggests that relugolix is a safe option for many prostate cancer patients. However, as with any treatment, individual experiences may differ, so discussing potential side effects with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Relugolix is unique because it offers a novel approach to treating prostate cancer by using an oral medication that targets the hormone pathways involved in cancer growth. Unlike traditional treatments like injectable hormone therapies, which can have delayed onset and require frequent clinic visits, relugolix is a once-daily pill that provides more convenient administration and potentially quicker reduction of testosterone levels, which is crucial in managing prostate cancer. Researchers are excited about relugolix because it combines effective hormone suppression with improved patient convenience, which could enhance quality of life for those undergoing treatment.

What evidence suggests that ORGOVYX is effective for prostate cancer?

Research has shown that relugolix, the treatment under study in this trial, effectively treats prostate cancer. One study found that over 90% of patients successfully lowered their testosterone to very low levels, a process known as castration. Another study demonstrated that relugolix quickly achieved this in both early and advanced stages of prostate cancer. Real-world studies also support its effectiveness, with more than 98% of patients reaching these low testosterone levels. Relugolix blocks signals that tell the body to produce testosterone, which prostate cancer cells need to grow. Overall, relugolix has proven to be very effective in controlling prostate cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Medical Monitor

Principal Investigator

Sumitomo Pharma

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Sumitomo Pharma America, Inc.

Lead Sponsor

Trials

244

Recruited

51,500+

Jatin Shah

Sumitomo Pharma America, Inc.

Chief Medical Officer since 2024

MD from an unspecified institution

Tsutomu Nakagawa

Sumitomo Pharma America, Inc.

Chief Executive Officer since 2024

MBA from Waseda University

Myovant Sciences GmbH

Lead Sponsor

Trials

23

Recruited

12,500+

Published Research Related to This Trial

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10198864/

Relugolix: A Review in Advanced Prostate Cancer - PMC In a key clinical trial in men with advanced prostate cancer, once-daily relugolix provided sustained castration in > 90% of patients, with a ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2004325

Oral Relugolix for Androgen-Deprivation Therapy in ... In this trial involving men with advanced prostate cancer, relugolix achieved rapid, sustained suppression of testosterone levels that was superior to that ...

3. onclive.com onclive.com/view/optyx-study-offers-preliminary-glance-into-real-world-use-of-relugolix-in-advanced-prostate-cancer

OPTYX Study Offers Preliminary Glance Into Real-World ... Data from OPTYX showed that most patients (52.2%) in the overall population (n = 999) received relugolix in combination with other prostate ...

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2815669

Efficacy and Safety of Radiotherapy Plus Relugolix in Men ... The results of these 2 randomized clinical trials suggest that relugolix rapidly achieves sustained castration in patients with localized and advanced prostate ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2950393025000816

Relugolix in prostate cancer therapy: Clinical evidence and ... Real-world studies performed to date have confirmed the effectiveness of relugolix, with more than 98% patients achieving castrate testosterone levels.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38451492/

Efficacy and Safety of Radiotherapy Plus Relugolix in Men ... The results of these 2 randomized clinical trials suggest that relugolix rapidly achieves sustained castration in patients with localized and advanced prostate ...

7. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0312481

Adverse events analysis of Relugolix (Orgovyx®) for prostate ... This study aims to comprehensively analyze the AEs associated with Relugolix (Orgovyx ® ) using data from the FAERS database, and gain a better understanding ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.85

Real-world experience on tolerability and safety of ... Median treatment exposure is 8 months (range 1 -21). All pts had baseline Testosterone >150ng/dL. All pts reached castrate T levels and 90% of ...

9. urotoday.com urotoday.com/conference-highlights/asco-gu-2025/asco-gu-2025-prostate-cancer/158172-asco-gu-2025-safety-and-tolerability-of-relugolix-in-combination-with-abiraterone-or-apalutamide-for-treatment-of-advanced-prostate-cancer-data-from-a-52-week-clinical-trial.html

ASCO GU 2025: Safety and Tolerability of Relugolix in ... No relevant post-treatment changes in the laboratory, ECG, or vital sign data were noted. The relugolix adherence rates were 98.5% in Part 1 and ...