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Relugolix + Enzalutamide Study for High-Risk Prostate Cancer

This study is testing a combination of two drugs, relugolix and enzalutamide, for men with high-risk locally advanced prostate cancer. The goal is to see if this combination can improve the chances of curing the cancer and help you live longer without the cancer getting worse. We're looking for men aged 18 or older with a confirmed diagnosis of prostate cancer that is considered high-risk (e.g., high PSA levels or advanced stage). The study will measure how many patients experience side effects and how well the treatment shrinks the cancer. The current status of the study is unclear, and it plans to enroll up to 46 participants.

Study design
This is an interventional study, meaning participants will receive the study drugs. It plans to enroll up to 46 participants, with an initial safety group of 3-12 patients followed by a larger group of up to 34 patients.
What's involved
You would take relugolix and enzalutamide for six months before other treatments, and then for an additional 18 months afterward. The total treatment cycle is 28 days.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you would be followed for approximately 24 months to assess the treatment's effectiveness and safety. The study will measure outcomes over 2-3 years and 4-6 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06130995

Relugolix + Enzalutamide Study in High-Risk Prostate Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Oklahoma
~46 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:Relugolix and Enzalutamide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patient experiencing dose limiting toxicity (DLT) and tolerable dose of relugolix and enzalutamide combination
Measured over 2-3 years
+1 more outcome measured

Conditions

Androgen Deprivation Therapy
Locally Advanced Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Oklahoma1

Who to contact

lead onco nurse, RN
[email protected]
405-271-8777
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Platelets ≥100 × 103/microliter (μL);
Hemoglobin ≥ 10.0 grams/dL;
Leukocytes (WBC) ≥ 3 × 103/μL;
Absolute neutrophil count ≥1.5 × 103/μL;
Serum AST and ALT ≤2.5 × upper limit of normal (ULN);
Total bilirubin ≤1.5 ×ULN (unless values are consistent with Gilbert's syndrome for which the total bilirubin must be \< 3x ULN);
Serum creatinine ≤ 1.5 × ULN; OR Measured or calculated creatinine clearance ≥30 mL/min for participant with creatinine levels \>1.5 × institutional ULN 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 6. The participant has, in the opinion of the investigator, a life expectancy of at least 6 months. 7. Male patients must be willing to use contraception during treatment and for 3 months after the last dose of study treatment when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential.

What this trial measures

  • Proportion of patient experiencing dose limiting toxicity (DLT) and tolerable dose of relugolix and enzalutamide combination2-3 years

    Proportion of patients will undergo evaluation for dose-limiting toxicity (DLT) to establish a tolerable dosage regimen for the combined use of relugolix and enzalutamide in individuals diagnosed with high-risk locally advanced prostate cancer. The assessment hinges on identifying DLTs associated with this treatment using 3-12 patients from the safety lead-in cohort and continuously monitoring treatment-related adverse events throughout the DLT observation period, which spans 24 months, encompassing neoadjuvant and adjuvant treatment phases.

  • Proportion of patients experiencing Pathologic Complete Response (pCR) and Minimal Residual Disease (MRD) in Neoadjuvant ADT with the combination of Relugolix and Enzalutamide4-6 years

    Proportion of patients achieving a pathologic response rate, defined as the combined Pathologic Complete Response (pCR) Rate and Minimal Residual Disease (MRD) rate (MRD, tumor ≤5 mm), serves as the primary endpoint for the dose expansion cohort. This assessment will be conducted using Simon's optimal 2-stage design, enabling a determination of whether there are an adequate number of patients with objective responses to proceed to the second stage of the study (at the interim analysis) or to consider the drug for further investigation in a Phase III study (at the study's conclusion).