RecruitingPhase 2interventionalRules rewrite

Phase 2: testing relugolix + ARPI for Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

This study wants to evaluate intermittent relugolix + androgen receptor pathway inhibitor (ARPI) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) achieving optimal PSA response.

Official registry: https://clinicaltrials.gov/study/NCT07216248 · University of Utah · enrollment listed as 160

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are relugolix + ARPI, Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI, or relugolix or androgen deprivation therapy (ADT) + ARPI. The registry lists allocation as randomized. This study wants to evaluate intermittent relugolix + androgen receptor pathway inhibitor (ARPI) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) achieving optimal PSA response.

They plan to enroll about 160 people at Salt Lake City. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase II Randomized, Decentralized, De-escalation Study in Patients With Metastatic Hormone-Sensitive Prostate Cancer Achieving Optimal PSA Response (OPTIMAS)

Interventions: relugolix + ARPI, Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI, relugolix or androgen deprivation therapy (ADT) + ARPI, relugolix + ARPI.

Primary outcome (registry wording): Cohort A: Brief Fatigue Inventory (BFI) score 6 months after randomization.

Who it is for (from inclusion criteria)

Ages 18 Years to any
Men only
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
how well you can do daily activities (ECOG score) ≤ 2

Who the registry excludes

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
Current evidence of uncontrolled, significant intercurrent illness, infection, non-compliance or other safety concerns which may affect clinical trial participation
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

Public study contact (from the registry)

Erynn Peyton

801-213-5601

Erynn.Peyton@hci.utah.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Huntsman Cancer Institute at University of Utah — Salt Lake City, Utah (recruiting)

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FAQ about this NCT record

Is NCT07216248 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07216248?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07216248?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary