Relugolix + ADT + ARPI for Prostate Cancer

(OPTIMAS Trial)

Overseen By Umang Swami, MD

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: University of Utah

Must be taking: Relugolix, ARPI

Disqualifiers: Other malignancy, Brain metastases, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a treatment plan for men with prostate cancer that has spread and still responds to hormones. Researchers aim to determine whether a combination of relugolix (a hormone therapy) and an androgen receptor pathway inhibitor (ARPI) is more effective when administered continuously or intermittently. Men with prostate cancer who have experienced metastasis and responded positively to initial hormone therapy may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant advancements in prostate cancer treatment.

Will I have to stop taking my current medications?

The trial does not clearly specify if you need to stop taking your current medications, but it mentions that participants taking prohibited medications as described in Section 6.6.2 are excluded. It's best to discuss your current medications with the study team to see if any are prohibited.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that relugolix, when used with ARPI (a type of prostate cancer medication), is generally safe for patients. In a year-long study, the side effects of relugolix combined with drugs like abiraterone or apalutamide were similar to those when these drugs are used alone, indicating no unexpected side effects from the combination.

Common side effects for individuals taking relugolix included hot flashes, tiredness, constipation, diarrhea, and joint pain. Notably, the study found that relugolix lowered the risk of major heart problems by 54% compared to another treatment.

Overall, this treatment appears safe for individuals with prostate cancer, as it has been thoroughly studied and used extensively. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments involving Relugolix for prostate cancer because it offers a novel approach compared to traditional androgen deprivation therapies (ADTs) like leuprolide. Relugolix is an oral medication that directly inhibits the release of hormones driving prostate cancer growth, unlike injectable alternatives that require clinic visits and can have delayed action. The trial is also exploring intermittent dosing, which could potentially reduce side effects and improve quality of life by allowing breaks in treatment while maintaining effectiveness. This could be a game-changer in balancing treatment efficacy with patient comfort.

What evidence suggests that this trial's treatments could be effective for metastatic hormone-sensitive prostate cancer?

Research has shown that combining relugolix with an androgen receptor pathway inhibitor (ARPI) effectively treats prostate cancer. In this trial, participants will receive continuous treatment with relugolix and ARPI. Studies have found that over 98% of patients achieve very low testosterone levels, crucial for controlling prostate cancer growth. Additionally, combining androgen deprivation therapy, such as relugolix, with ARPI improves outcomes in treating hormone-sensitive prostate cancer. This combination helps maintain the necessary hormone levels to control the cancer. These findings suggest that this treatment could be highly effective for patients with metastatic hormone-sensitive prostate cancer. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for men with metastatic hormone-sensitive prostate cancer who have achieved an optimal PSA response. Specific eligibility details are not provided, but typically participants must meet certain health criteria and not have conditions that would exclude them from safely participating.

Inclusion Criteria

Cohort A Eligibility (Step 2 Registration): PSA ≤ 0.2 ng/mL after treatment with specified drugs

I am over 18, have hormone-sensitive prostate cancer without small cell features, my cancer has spread (seen on scans), my testosterone is above 50 ng/dl, my PSA is at least 1 ng/mL, I can take care of myself but might not be able to work or do heavy physical activities, I am eligible for standard treatment, I agree to use birth control, any previous treatment side effects are stable or resolved, I have a smartphone, and I can consent to treatment.

I am over 18, have hormone-sensitive prostate cancer without small cell histology, no metastasis on imaging, PSA ≤ 0.2 ng/mL after treatment, can follow standard treatment, willing to use contraception, have a smartphone, and can consent.

Exclusion Criteria

I have not been excluded due to prior therapy, illness, safety concerns, or medication issues.

I am not on any other cancer treatments, have castration-resistant prostate cancer, no other cancers, and am not taking prohibited medications.

I am not receiving other cancer treatments, have no major health issues, and am not taking prohibited medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive continuous treatment with relugolix + ARPI for 6-12 months

6-12 months

Randomization and Treatment

Participants with optimal PSA response are randomized to either continue continuous treatment or switch to intermittent treatment

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• ARPI
• Relugolix

Trial Overview The study is testing intermittent use of a drug called Relugolix combined with an androgen receptor pathway inhibitor (ARPI) to see how well it works in managing prostate cancer compared to standard androgen deprivation therapy (ADT) plus ARPI.

How Is the Trial Designed?

Group I: Cohort B Experimental Treatment 1 Intervention

Participants who have achieved PSA ≤ 0.2 ng/mL are eligible and will receive intermittent treatment with relugolix + ARPI.

Group II: Cohort A: Arm 2 Experimental Treatment 2 Interventions

INDUCTION (Step 1): Participants will receive continuous treatment with relugolix + an androgen receptor pathway inhibitor (ARPI). After 6-12 months of continuous treatment, participants whose PSA is ≤ 0.2 ng/mL and who have completed step two registration will be randomized to one of two treatment arms: • Cohort A: Arm 2 will receive intermittent treatment with relugolix + ARPI.

Group III: Cohort A: Arm 1 Active Control 2 Interventions

INDUCTION (Step 1): Participants will receive continuous treatment with relugolix + an androgen receptor pathway inhibitor (ARPI). After 6-12 months of continuous treatment, participants whose PSA is ≤ 0.2 ng/mL and who have completed step two registration will be randomized to one of two treatment arms: • Cohort A: Arm 1 will continue standard-of-care, continuous treatment with relugolix or androgen deprivation therapy (ADT) + ARPI per clinical investigator.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12307536/

Relugolix in Combination with Androgen Receptor ... The results of a phase II sub-study demonstrate that the coadministration of relugolix and apalutamide effectively maintained castrate ...

2. 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.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.156

Safety and tolerability of relugolix in combination with ... Combining ADT with androgen receptor signaling inhibitors (ARSIs) has shown improved clinical outcomes in hormone-sensitive and castration- ...

4. tandfonline.com tandfonline.com/doi/full/10.2217/fon-2023-0748

Evaluating relugolix for the treatment of prostate cancer in ... The most common adverse events (AEs) observed in relugolix-treated patients were hot flash, fatigue, constipation, diarrhea and arthralgia [Citation16].

5. onclive.com onclive.com/view/dr-dorff-on-a-real-world-study-of-relugolix-in-advanced-prostate-cancer

Dr Dorff on a Real-World Study of Relugolix in Advanced ... Tanya B. Dorff, MD, discusses the clinical characteristics and treatment preferences for initiating relugolix during prostate cancer treatment.

6. 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 ... In this 52-week study, the oral testosterone-lowering drug relugolix was studied in patients with advanced prostate cancer in combination with ...