Actively Recruiting
Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
Led by University of Utah · Updated on 2025-10-29
160
Participants Needed
1
Research Sites
309 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participant aged 18 years or older
- Hormone-sensitive prostate cancer with histologically or cytologically confirmed adenocarcinoma without small cell histology
- Metastasis detected before study registration by conventional or functional imaging
- Baseline testosterone greater than 50 ng/dL before starting therapy for metastatic disease
- PSA level 1 ng/mL or higher for Step 1 registration (Cohort A)
- PSA level 0.2 ng/mL or lower after 6-12 months of relugolix and ARPI treatment for Step 2 registration (Cohort A)
- PSA level 0.2 ng/mL or lower after androgen deprivation therapy or ARPI treatment of any duration for Cohort B
- ECOG Performance Status of 2 or less
- Eligible to receive standard care with relugolix and ARPI
- Agreement to use highly effective contraception if having a sexual partner of childbearing potential
- Agreement to use condoms if risk of seminal transfer exists
- Agreement not to donate sperm from start of therapy until 3 months after last dose
- Clinically stable from adverse effects of prior cancer treatments
- Access to smartphone and wireless services and ability to use study applications
- Able and willing to provide informed consent
You will not qualify if you...
- Prior androgen deprivation therapy defined as leuprolide or surgical castration for metastatic hormone-sensitive prostate cancer (Cohort A Step 1)
- Diagnosis of another malignancy that may impact safety or study participation
- Known brain metastases or cranial epidural disease unless treated and stable for at least 4 weeks
- Uncontrolled illness, infection, or other safety concerns affecting participation
- Medical, psychiatric, cognitive, or other conditions affecting ability to understand, consent, comply, or complete the study
- Known severe hypersensitivity to investigational product or its components
- Taking prohibited medications as specified in the protocol
- Receiving other systemic anti-cancer therapy for prostate cancer at Step 2 registration or in Cohort B
- History of surgical castration (Cohort B)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
Research Team
E
Erynn Peyton
CONTACT
U
Umang Swami, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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