Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT07216248
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 27, 2025
Status verified
Oct 2025
Primary completion
Oct 31, 2030
Completion
Oct 31, 2031

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Cohort A: Arm 1
    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.
  • Experimental: Cohort A: Arm 2
    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.
  • Experimental: Cohort B
    Participants who have achieved PSA ≤ 0.2 ng/mL are eligible and will receive intermittent treatment with relugolix + ARPI.

Primary Outcome Measure

Cohort A: Brief Fatigue Inventory (BFI) score 6 months after randomization. [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer Institute at University of UtahSalt Lake CityUtah84112
Erynn Peyton
[email protected]
801-213-5601
Umang Swami, MD
[email protected]
801-585-0255

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By research site
Huntsman Cancer Institute at University of Utah· Salt Lake City, UT

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