New pill combo aims to boost prostate cancer cure rates
NCT ID NCT06130995
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing whether taking two hormone-blocking pills—relugolix and enzalutamide—before and after standard radiation or surgery can help cure high-risk locally advanced prostate cancer. About 46 men will participate to first find a safe dose, then see if the combo shrinks tumors more effectively. The study is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- relugolix and enzalutamide (hormone-blocking pills)
- What this could lead to
- If this combination works, it could improve the chance of curing high-risk prostate cancer and help patients live longer without the cancer returning.
- What could go wrong
- This is a very early Phase 1 trial with only 46 people, so the main goal is to find a safe dose. It is too soon to know if the combination actually improves cure rates or survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Capable of giving signed informed consent; 2. Patients must be ≥18 years of age at the time of signing the informed consent form. 3. Men with a diagnosis of adenocarcinoma of the prostate pathologically proven diagnosis with the following: • Locally advanced high-risk prostate defined as i. PSA \>20 ng/mL or ISUP grade 4/5 (Gleason score \>7) or cT2c or ii. Any PSA, any ISUP grade, cT3-4 or cN+ (locally advanced) 4. Have normal organ and bone marrow function measured at the screening visit including * 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. Exclusion Criteria: 1. History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 6 months. 2. Patients who are receiving any other investigational agents. 3. Patients with distant metastatic cancer will be excluded from the study as intermittent hormonal therapy is not standard of care treatment for this population. 4. Active secondary malignancies requiring treatment 5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of study drugs 6. Participants with uncontrolled intercurrent illness. 7. Participant is unable to swallow pills. 8. Not a candidate for surgical or radiation therapy
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Stephenson Cancer Center at OU Health, University of Oklahoma Health Sciences Center (SCC-OUHSC)
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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Other studies related to the condition(s) this trial covers.
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- Exercise may counteract side effects of prostate cancer hormone therapy
- New trial aims to halt prostate cancer spread with targeted radiation
- Could a menopause drug cool hot flashes in men with prostate cancer?
- Exercise program aims to protect hearts of black men on prostate cancer treatment