Actively Recruiting
A Phase II Randomized, Decentralized De-escalation Study in Patients With Metastatic Hormone-Sensitive Prostate Cancer Achieving Optimal PSA Response
Led by University of Utah · Updated on 2025-10-29
160
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating intermittent relugolix combined with an androgen receptor pathway inhibitor (ARPI) in men with metastatic hormone-sensitive prostate cancer (mHSPC) who have achieved an optimal PSA response. This Phase II randomized trial aims to study different treatment schedules after initial continuous therapy, focusing on men whose PSA levels reach 0.2 ng/mL or less following 6 to 12 months of therapy. The study explores whether intermittent treatment can maintain disease control while potentially reducing side effects compared to continuous therapy. Participants begin with an induction period involving continuous treatment with relugolix plus an ARPI. After 6 to 12 months, those with PSA levels at or below 0.2 ng/mL are randomized into two groups: one continues standard continuous treatment with relugolix or androgen deprivation therapy (ADT) plus ARPI, while the other receives intermittent treatment with relugolix plus ARPI. Another cohort includes participants who have already achieved the PSA threshold and receive intermittent treatment. The study monitors the effects of these approaches on fatigue, progression-free survival, quality of life, sexual function, hot flashes, cognitive function, and testosterone recovery over months to years. During the study, participants undergo assessments including fatigue inventories, quality of life questionnaires, and cognitive function tests at various time points up to three years. The research team measures progression-free survival, overall survival, time to treatment changes, and testosterone levels, among other outcomes. Participants are also monitored for adverse effects and treatment adherence, using smartphone applications for study navigation. The total study duration varies by participant based on their treatment arm and response, with follow-up assessments extending up to three years after randomization.
CONDITIONS
Brief Title
Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 years or older
- Histologically or cytologically confirmed hormone-sensitive prostate adenocarcinoma without small cell histology
- Metastasis detected before study registration by imaging
- Baseline testosterone greater than 50 ng/dl before starting metastatic disease therapy
- PSA level of 1 ng/mL or higher at baseline
- ECOG Performance Status of 2 or less
- Eligible for treatment with relugolix and androgen receptor pathway inhibitor (ARPI) as determined by the investigator
- Agreement to use highly effective contraception if having a sexual partner of childbearing potential
- Agreement to use condoms and not donate sperm during study therapy and for 3 months after last dose if seminal transfer risk exists
- Resolved or stable adverse effects from prior cancer treatments
- Access to a smartphone and wireless service and ability to use study applications
- Able to provide informed consent and willing to sign consent form
- PSA level of 0.2 ng/mL or less after 6-12 months of relugolix and ARPI treatment for Step 2 registration (Cohort A)
- PSA level of 0.2 ng/mL or less after androgen deprivation therapy or ARPI treatment for Cohort B
You will not qualify if you...
- Prior androgen deprivation therapy for metastatic hormone-sensitive prostate cancer (leuprolide or surgical castration) for Step 1 registration
- Diagnosis of another malignancy likely to affect safety or participation
- Known brain metastases or cranial epidural disease unless treated and stable for at least 4 weeks before study treatment
- Uncontrolled significant illness, infection, or safety concerns affecting participation
- Medical, psychiatric, cognitive, or other conditions impairing consent or study compliance
- Severe hypersensitivity to study drugs or components
- Use of prohibited medications as described in study protocol
- Receiving other systemic anti-cancer therapy for prostate cancer at Step 2 registration or Cohort B
- Progression to metastatic castration-resistant prostate cancer
- History of surgical castration (Cohort B)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 12 months
Participants receive continuous treatment with relugolix plus an androgen receptor pathway inhibitor (ARPI) for 6 to 12 months to achieve optimal PSA response.
Regular visits during treatment
Duration - Up to 12 months
Participants who achieve a PSA level of 0.2 ng/mL or less after induction are randomized to receive either continuous or intermittent treatment with relugolix or androgen deprivation therapy (ADT) plus ARPI.
Visits scheduled according to assigned treatment arm
Duration - Up to 12 months
Participants in Cohort B who have achieved PSA ≤ 0.2 ng/mL receive intermittent treatment with relugolix plus ARPI.
Visits scheduled according to intermittent treatment regimen
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
U
Umang Swami, MD
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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