Metastatic Hormone-sensitive Prostate Cancer (mHSPC)Phase 2OPTIMASNCT07216248
Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer
A Phase 2 study testing relugolix + ARPI, Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI and relugolix or androgen deprivation therapy (ADT) + ARPI in people with Metastatic Hormone-sensitive Prostate Cancer (mHSPC), run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
- What is being tested?
- relugolix + ARPI, Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI and relugolix or androgen deprivation therapy (ADT) + ARPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2025to Oct 2031
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
Erynn Peyton, 801-213-5601, Erynn.Peyton@hci.utah.edu
Umang Swami, MD, 801-585-0255, Umang.Swami@hci.utah.edu
About this study
Official title: A Phase II Randomized, Decentralized, De-escalation Study in Patients With Metastatic Hormone-Sensitive Prostate Cancer Achieving Optimal PSA Response (OPTIMAS)
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.
- Being tested
- relugolix + ARPI, Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI, relugolix or androgen deprivation therapy (ADT) + ARPI, relugolix + ARPI.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relugolix + ARPIDrug
Step 1: Continuous treatment with relugolix + ARPI
Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPIDrug
Intermittent treatment with relugolix + ARPI.
relugolix or androgen deprivation therapy (ADT) + ARPIDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Arm 1 | Active comparator | 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. Receives: Drug: relugolix + ARPI; Drug: relugolix or androgen deprivation therapy (ADT) + ARPI |
| Cohort A: Arm 2 | Experimental | 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. Receives: Drug: relugolix + ARPI; Drug: relugolix + ARPI. |
| Cohort B | Experimental | Participants who have achieved PSA ≤ 0.2 ng/mL are eligible and will receive intermittent treatment with relugolix + ARPI. Receives: Drug: Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort A: Brief Fatigue Inventory (BFI) score 6 months after randomization.
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).
Measured: 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.
To assess PFS in patients with mHSPC on intermittent relugolix/ADT + ARPI at one year.
Measured: 12 months
Secondary outcomes (19)
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).
To evaluate treatment effects on patient-reported outcomes (PROs). EORTC-QLQC30 scored from 1 (not at all)- 4 (very much).
Measured: 13 months
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).
To evaluate treatment effects on patient-reported outcomes (PROs). EORTC-QLQ-PR25 scored from 1 (not at all)- 4 (very much).
Measured: 13 months
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.
To evaluate treatment effects on patient-reported outcomes (PROs). EORTC-QLQ-PR25, question 52-55.Scored from 1 (not at all)- 4 (very much).
Measured: 13 months
Changes in severity of hot flashes as measured by the Hot Flash Related Daily Interference Scale (HFRDIS).
To evaluate treatment effects on patient-reported outcomes (PROs). HFRDIS scored 0 (did not interfere to 10 (completely interfered).
Measured: 13 months
Changes in cognitive function as measured by the PROMIS-Cognitive function Short Form 8a.
To evaluate treatment effects on patient-reported outcomes (PROs). PROMIS-Cognitive function Short Form 8a scored 5 (Never)- 1 (very often- Several times a day).
Measured: 13 months
Change from baseline over time in each PRO, including time to recovery and deterioration in the intermittent arm with treatment break and start.
To evaluate treatment effects on patient-reported outcomes (PROs).
Measured: 2 years
Time to metastatic castration-resistant prostate cancer.
Cohort A: To determine if intermittent relugolix + ARPI will provide similar efficacy as continuous relugolix/ADT + ARPI in clinically relevant endpoints in participants with mHSPC who reached PSA ≤0.2 ng/mL after 6-12 months of relugolix+ARPI treatment.
Cohort B: To evaluate the treatment efficacy of intermittent relugolix/ADT + ARPI.
Measured: 12 months
Overall survival and prostate cancer-specific survival at 3 years from the date of randomization.
Cohort A: To determine if intermittent relugolix + ARPI will provide similar efficacy as continuous relugolix/ADT + ARPI in clinically relevant endpoints in participants with mHSPC who reached PSA ≤0.2 ng/mL after 6-12 months of relugolix+ARPI treatment.
Cohort B: Change from baseline over time in each PRO, including time to recovery and deterioration in intermittent arm with treatment break and start.
Measured: 12 months
Time to systemic treatment change.
To determine if intermittent relugolix + ARPI will provide similar efficacy as continuous relugolix/ADT + ARPI in clinically relevant endpoints in participants with mHSPC who reached PSA ≤0.2 ng/mL after 6-12 months of relugolix+ARPI treatment
Measured: 12 months
Duration of time on treatment
Cohort A: To determine if intermittent relugolix + ARPI will provide similar efficacy as continuous relugolix/ADT + ARPI in clinically relevant endpoints in participants with mHSPC who reached PSA ≤0.2 ng/mL after 6-12 months of relugolix+ARPI treatment.
Cohort B: To evaluate the treatment efficacy of intermittent relugolix/ADT + ARPI.
Measured: 12 months
Time to first treatment restart
Cohort A: To determine if intermittent relugolix + ARPI will provide similar efficacy as continuous relugolix/ADT + ARPI in clinically relevant endpoints in participants with mHSPC who reached PSA ≤0.2 ng/mL after 6-12 months of relugolix+ARPI treatment.
Cohort B: To evaluate the treatment efficacy of intermittent relugolix/ADT + ARPI.
Measured: 12 months
Duration of time with testosterone < 50 ng/mL
Cohort A: To determine if intermittent relugolix + ARPI will provide similar efficacy as continuous relugolix/ADT + ARPI in clinically relevant endpoints in participants with mHSPC who reached PSA ≤0.2 ng/mL after 6-12 months of relugolix+ARPI treatment.
Cohort B: To evaluate the treatment efficacy of intermittent relugolix/ADT + ARPI.
Measured: 12 months
Testosterone-linked outcomes (time to recovery of testosterone ≥50 ng/dL; time to recovery of testosterone to baseline [≥screening testosterone level]).
Cohort A: To determine if intermittent relugolix + ARPI will provide similar efficacy as continuous relugolix/ADT + ARPI in clinically relevant endpoints in participants with mHSPC who reached PSA ≤0.2 ng/mL after 6-12 months of relugolix+ARPI treatment.
Cohort B: To evaluate the treatment efficacy of intermittent relugolix/ADT + ARPI.
Measured: 12 months
Duration of time to recovery of testosterone to normal range [>300 ng/dL]).
Cohort A: To determine if intermittent relugolix + ARPI will provide similar efficacy as continuous relugolix/ADT + ARPI in clinically relevant endpoints in participants with mHSPC who reached PSA ≤0.2 ng/mL after 6-12 months of relugolix+ARPI treatment.
Cohort B: To evaluate the treatment efficacy of intermittent relugolix/ADT + ARPI.
Measured: 12 months
The proportion of participants achieving a treatment-free interval (TFI) of at least one year from the time of registration and median TFI.
To assess the TFI at one year in patients achieving optimal PSA response.
Measured: 12 months
Change in Brief Fatigue Inventory (BFI) score from baseline to 6 months after registration.
To assess the change in quality of life measures from baseline. BFI Scored from 0 (no Fatigue) to 10 (as bad as you can imagine), and 0 (Does not interfere) to 10 (Completely Interferes).
Measured: 6 months
Changes in cognitive function as measured by the PROMIS-Cognitive Function Short Form 8a.
To assess the change in quality of life measures from baseline. PROMIS-Cognitive function Short Form 8a scored 5 (Never)- 1 (very often- Several times a day).
Measured: 13 months
Change from baseline over time in each PRO, including time to recovery and deterioration in intermittent arm with treatment break and start.
To assess the change in quality of life measures from baseline.
Measured: 13 months
Overall survival and prostate cancer specific survival at 3 years from the date of randomization.
To evaluate the treatment efficacy of intermittent relugolix + ARPI.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2025
- Study start27 Oct 2025
- Primary completionOct 2030 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Hormone-sensitive Prostate Cancer (mHSPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216248
- Sponsor's protocol ID
- HCI194008
- Acronym
- OPTIMAS
- Status last verified
- Oct 2025
- First submitted
- 30 Sep 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No