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New cocktail aims to wipe out prostate cancer before surgery

NCT ID NCT07516704

Disease control Sponsor: Zhongda Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests whether adding two drugs (darolutamide and homoharringtonine) to standard chemo and hormone therapy can more thoroughly clear high-risk prostate cancer before surgery. About 94 men will receive the combo for 7 weeks, then have their prostate removed to check for remaining cancer. The goal is to see if this approach leads to a complete or near-complete response in the tumor.

What this could mean

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

Active substance
docetaxel, darolutamide, homoharringtonine, and androgen deprivation therapy
What this could lead to
If successful, this could point toward a more effective pre-surgery treatment for high-risk prostate cancer, potentially improving long-term outcomes.
What could go wrong
This is a very early, small trial (94 people) with no control group, so results may not be conclusive. The drug combination also carries risks like infection, fatigue, and bleeding.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 94 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

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 85 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: * ① Age ≥ 18 years and ≤ 85 years; * Histologically or cytologically confirmed prostate cancer; * High-risk prostate cancer: meeting at least one of the following criteria: clinical stage T3-T4, or Gleason score 8-10, or PSA \> 20 ng/mL, or presence of distant metastasis (clinical stage M1); ④ ECOG (Eastern Cooperative Oncology Group) performance status score of 0-1; ⑤ All patients voluntarily sign informed consent and are able to adhere to treatment and follow-up Exclusion Criteria: * ① Any prior or ongoing treatment for prostate cancer, including radiotherapy, chemotherapy, ADT, etc.; * Previous prostatectomy; ③ Any other serious underlying medical, psychiatric, or psychological conditions that, in the investigator's judgment, may affect treatment; * Allergy to any of the study drugs; ⑤ Refusal to undergo radical prostatectomy; ⑥ Deemed unsuitable for participation in this clinical trial by the investigator's judgment.

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. 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 ↗

  2. 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.

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