Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexMale
• Healthy volunteersNo

You may be able to join if

• Cohort A Eligibility (Step 1 Registration)
• 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.
• Cohort A Eligibility (Step 2 Registration) -PSA ≤ 0.2 ng/mL after 6-12 months of relugolix and androgen receptor pathway inhibitor treatment. Androgen receptor pathway inhibitor includes abiraterone, enzalutamide, apalutamide, darolutamide or similar drugs.
• Cohort B Eligibility
• 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.

You cannot join if

• Cohort A Eligibility (Step 1 Registration)
• 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.
• Cohort A Eligibility (Step 2 Registration)
• 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.
• Cohort B Eligibility
• 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

relugolix. An orally available, non-peptide gonadotropin-releasing hormone (GnRH or luteinizing hormone-releasing hormone (LHRH)) antagonist, with potential antineoplastic activity. Relugolix competitively binds to and blocks the GnRH receptor in the anterior pituitary gland, which both prevents GnRH binding to the GnRH receptor and inhibits the secretion and release of both luteinizing hormone (LH) and follicle stimulating hormone (FSH). In males, the inhibition of LH secretion prevents the release of testosterone from Leydig cells in the testes. Since testosterone is required to sustain prostate growth, reducing testosterone levels may inhibit hormone-dependent prostate cancer cell proliferation. NCI Drug Dictionary

Treatments listed in the registry

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

Randomized · Parallel · masking: None

Main goals

• Cohort A: Brief Fatigue Inventory (BFI) score 6 months after randomization. (6 months)
• 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)

Other goals

• Changes in health-related quality of life as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC-QLQC30).
• Changes in health-related quality of life as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC-QLQ-PR25).
• Sexual function improvement in those with intact sexual function at baseline as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire.
• Changes in severity of hot flashes as measured by the Hot Flash Related Daily Interference Scale (HFRDIS).
• Changes in cognitive function as measured by the PROMIS-Cognitive function Short Form 8a.
• Change from baseline over time in each PRO, including time to recovery and deterioration in the intermittent arm with treatment break and start.
• Time to metastatic castration-resistant prostate cancer.
• Overall survival and prostate cancer-specific survival at 3 years from the date of randomization.
• Time to systemic treatment change.
• Duration of time on treatment
• Time to first treatment restart
• Duration of time with testosterone < 50 ng/mL
• Testosterone-linked outcomes (time to recovery of testosterone ≥50 ng/dL; time to recovery of testosterone to baseline [≥screening testosterone level]).
• Duration of time to recovery of testosterone to normal range [>300 ng/dL]).
• The proportion of participants achieving a treatment-free interval (TFI) of at least one year from the time of registration and median TFI.
• Change in Brief Fatigue Inventory (BFI) score from baseline to 6 months after registration.
• Changes in cognitive function as measured by the PROMIS-Cognitive Function Short Form 8a.
• Change from baseline over time in each PRO, including time to recovery and deterioration in intermittent arm with treatment break and start.
• Overall survival and prostate cancer specific survival at 3 years from the date of randomization.

Planned enrollment: 160 (estimated).

• Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07216248
• NCI Drug Dictionary: C114498

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jun 22, 2026. Public record; not medical advice.