RecruitingPhase 2NCT07216248

Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer

A Phase II Randomized, Decentralized, De-escalation Study in Patients With Metastatic Hormone-Sensitive Prostate Cancer Achieving Optimal PSA Response (OPTIMAS)


Sponsor

University of Utah

Enrollment

160 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate intermittent relugolix + androgen receptor pathway inhibitor (ARPI) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) achieving optimal PSA response.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called OPTIMA) is testing an individualized approach to managing hormone-sensitive prostate cancer that has spread to other parts of the body. Instead of continuous hormone therapy, it uses PSA blood test levels to guide when to start and stop treatment, aiming to maintain quality of life while keeping the cancer controlled. **You may be eligible if...** - You are 18 or older and have confirmed metastatic hormone-sensitive prostate cancer - Your PSA level is 1 ng/mL or higher at the start - You are functional (ECOG 0–2) - For Cohort A: You have not yet received hormone-blocking therapy for metastatic disease - For Cohort B: Your PSA has already dropped below 0.2 ng/mL from hormone therapy - You have a smartphone and can use study apps **You may NOT be eligible if...** - You have already received standard hormone therapy (leuprolide or surgical castration) for metastatic disease (Cohort A) - You have brain or spinal fluid metastases that are not adequately treated - You have another active cancer - You have a condition that would prevent you from safely participating Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGrelugolix + ARPI

Step 1: Continuous treatment with relugolix + ARPI

DRUGIntermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI

Intermittent treatment with relugolix + ARPI.

DRUGrelugolix or androgen deprivation therapy (ADT) + ARPI

Step 2: Standard-of-care, continuous treatment with relugolix or androgen deprivation therapy (ADT) + ARPI.

DRUGrelugolix + ARPI.

Step 2: Intermittent treatment with relugolix + ARPI.


Locations(1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

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NCT07216248


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