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New drug cocktail aims to keep prostate cancer away after surgery

NCT ID NCT07444983

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether the drug rezvilutamide, combined with standard hormone therapy, can prevent high-risk prostate cancer from coming back after surgical removal. About 33 participants will take the pills and get injections for up to 2 years. The main goal is to see how many stay cancer-free for 3 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rezvilutamide (a drug taken orally) and leuprorelin (a hormone therapy injection)
What this could lead to
If it works, this could help prevent high-risk prostate cancer from returning after surgery, offering a new option to keep patients cancer-free longer.
What could go wrong
This is a small, early exploratory study with only 33 people, so results may not apply broadly. The treatment lasts 2 years and may cause side effects like fatigue, hot flashes, or liver issues.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 33 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

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 to 95 years

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 Subjects must meet all of the following criteria to be eligible for entry into this study: Age ≥ 18 years. Histologically confirmed adenocarcinoma of the prostate following radical prostatectomy. Evaluated by the investigator as requiring pharmacological treatment. ECOG Performance Status of 0 or 1. Preoperative imaging ruled out metastatic disease. Must meet at least one of the following postoperative high-risk factors: Positive surgical margins; Pathological stage pT3-pT4; Lymph node metastasis; Preoperative PSA ≥ 20 ng/ml. Unwilling to receive postoperative radiotherapy. PSA \< 0.1 ng/ml during the screening period. Capable of understanding and voluntarily signing the Informed Consent Form (ICF). Exclusion Criteria Patients meeting any of the following criteria will be excluded from the study: Postoperative pathology contains non-adenocarcinoma components, such as neuroendocrine differentiation or small cell features. Known or suspected hypersensitivity to Rezvilutamide or any of its excipients. Factors affecting drug administration or absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction. History of seizures or presence of conditions predisposing to seizures within 12 months prior to screening (including history of transient ischemic attack, stroke, or traumatic brain injury with loss of consciousness requiring hospitalization). Active cardiac disease within 6 months prior to screening, including: severe/unstable angina, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medical treatment. History of other malignancies within 3 years prior to screening (except for completely remitted carcinoma in situ or malignancies judged by the investigator to be slow-progressing). Active HBV or HCV infection (HBV DNA ≥ 10\^4 copies/mL, HCV RNA ≥ 10\^3 copies/mL). History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases) or history of organ transplantation. Male subjects with female partners of childbearing potential who refuse surgical sterilization or refuse to use effective contraception during the study period. Any other condition which, in the opinion of the investigator, may interfere with the conduct of the study, compromise protocol compliance, or pose an unacceptable risk to the subject.

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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.

  1. The places running it

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

  2. 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 ↗

  3. 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

Locations

  • Department of Urology, Fujian Union Hospital, Fujian Medical University

    Fuzhou, Fujian, 350000, China

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