NCT07216248

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University of Utah · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Interventions

Type	Name	Description
DRUG	relugolix + ARPI	Step 1: Continuous treatment with relugolix + ARPI
DRUG	Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI	Intermittent treatment with relugolix + ARPI.
DRUG	relugolix or androgen deprivation therapy (ADT) + ARPI	Step 2: Standard-of-care, continuous treatment with relugolix or androgen deprivation therapy (ADT) + ARPI.
DRUG	relugolix + ARPI.	Step 2: Intermittent treatment with relugolix + ARPI.

Timeline

• Start date: 2025-10-27
• Primary completion: 2030-10-01
• Completion: 2031-10-01
• First posted: 2025-10-14
• Last updated: 2025-10-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study