Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
This study is looking at a new way to treat metastatic hormone-sensitive prostate cancer (mHSPC), which is prostate cancer that has spread to other parts of the body and still responds to hormone therapy. Researchers are testing if giving relugolix and an ARPI (androgen receptor pathway inhibitor) intermittently (on and off) is as effective as continuous treatment. The study aims to see if this intermittent approach can reduce side effects like fatigue while keeping the cancer under control. You might be able to join if you are an adult male with mHSPC that has spread and you've achieved a good response to initial treatment. The study will measure how fatigue changes and how long patients live without their cancer getting worse. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 160 participants. It compares continuous treatment with intermittent treatment using relugolix and ARPI.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- For some participants, fatigue will be measured at 6 months. For others, progression-free survival will be measured at 12 months after starting intermittent treatment.
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NCT07216248
Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of UtahInvestigator-initiated
~160 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:relugolix + ARPIIntermittent- Relugolix or androgen deprivation therapy (ADT) + ARPIrelugolix or androgen deprivation therapy (ADT) + ARPIrelugolix + ARPI.
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort A: Brief Fatigue Inventory (BFI) score 6 months after randomization.
Measured over 6 months
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesUtah1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Participant aged ≥ 18 years
Hormone-sensitive prostate cancer with histologically/cytologically confirmed adenocarcinoma without small cell histology.
Metastasis detected any time prior to study registration on conventional or functional imaging as determined by the treating investigator and can be of any site.
Baseline testosterone \>50 ng/dl before start of therapy for metastatic disease
PSA ≥ 1 ng/mL before start of therapy for metastatic disease
ECOG Performance Status ≤ 2
Eligible to receive standard of care treatment with relugolix and APRI per clinical investigator.
Participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception requirements as described in Section 5.5.1.
If the risk of seminal transfer from the participant is present, the participant must agree to use a condom during sexual intercourse as described in Section 5.5.2.
Participants must agree not to donate sperm from the start of study therapy until 3 months after the last dose of study therapy.
Clinically significant adverse effects from any prior oncologic treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy) must have resolved or have been determined to be clinically stable per the Investigator.
Has access to a smartphone and wireless services and is able to download and navigate study specific applications.
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Participant aged ≥ 18 years
Hormone-sensitive prostate cancer with histologically/cytologically confirmed adenocarcinoma without small cell histology.
Metastasis detected any time prior to study registration on conventional or functional imaging as determined by clinical investigator and can be of any site.
PSA ≤ 0.2 ng/mL after treatment with androgen deprivation therapy or androgen receptor pathway inhibitor treatment or both of any duration. Androgen deprivation therapy in this context includes gonadotropin-releasing hormone agonists and antagonists. Androgen receptor pathway inhibitors include abiraterone, enzalutamide, apalutamide, darolutamide or similar drugs.
Eligible to receive standard of care treatment with relugolix and APRI per clinical investigator.
Participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception requirements as described in Section 5.5.1.
If the risk of seminal transfer from the participant is present, the participant must agree to use a condom during sexual intercourse as described in Section 5.5.2.
Participants must agree not to donate sperm from the start of study therapy until 3 months after the last dose of study therapy.
Has access to a smartphone and wireless services and is able to download and navigate study specific applications.
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion
Participant received androgen deprivation therapy (defined as leuprolide or surgical castration) for metastatic hormone-sensitive prostate cancer.
The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.
Known brain metastases or cranial epidural disease.
Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Participants must be neurologically stable and receiving a stable or decreasing corticosteroid dose at the time of study entry.
Current evidence of uncontrolled, significant intercurrent illness, infection, non-compliance or other safety concerns which may affect clinical trial participation.
Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v5.0 Grade ≥ 3).
Participants taking prohibited medications as described in Section 6.6.2.
Receiving other systemic anti-cancer therapy for prostate cancer. Prior treatment before Step 2 registration is allowed.
Progression to metastatic castration-resistant prostate cancer per clinical investigator.
The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.
Participants taking prohibited medications as described in Section 6.6.2.
Receiving other systemic anti-cancer therapy for prostate cancer.
History of surgical castration.
The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.
Known brain metastases or cranial epidural disease.
Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Participants must be neurologically stable and receiving a stable or decreasing corticosteroid dose at the time of study entry
Current evidence of uncontrolled, significant intercurrent illness, infection, compliance or other safety concerns which may affect clinical trial participation.
Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v5.0 Grade ≥ 3).
Participants taking prohibited medications as described in Section 6.6.1.
What this trial measures
- Cohort A: Brief Fatigue Inventory (BFI) score 6 months after randomization.6 months
To assess the difference in fatigue 6 months after randomization in patients with mHSPC achieving optimal PSA response on intermittent relugolix + ARPI versus continuous relugolix/ADT + ARPI. Scored from 0 (no Fatigue) to 10 (as bad as you can imagine), and 0 (Does not interfere) to 10 (Completely Interferes).
- Cohort B: Progression-free survival (PFS) as defined as the time from intermittent study initiation (first treatment break) to the time of documented disease progression or death from any cause at one year.12 months
To assess PFS in patients with mHSPC on intermittent relugolix/ADT + ARPI at one year.