Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New pill combo aims to boost prostate cancer cure rates

NCT ID NCT06130995

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 46 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Male participants only

Healthy volunteers

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Androgen deprivation therapy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Neoplasm, Residual Pathologic Complete Response prostate cancer prostate carcinoma

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Stephenson Cancer Center at OU Health, University of Oklahoma Health Sciences Center (SCC-OUHSC)

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.