Could a traditional chinese medicine compound boost prostate cancer treatment?

NCT ID NCT07163910

Disease control Sponsor: baotai Liang Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests whether adding homoharringtonine (a drug from a Chinese evergreen plant) to standard hormone therapy before prostate removal can improve outcomes for men with high-risk or advanced prostate cancer. About 93 participants will receive the drug combination before surgery, and researchers will measure how many achieve a complete or major response. The goal is to find a more effective neoadjuvant treatment for this aggressive cancer.

What this could mean

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

Active substance: homoharringtonine (a plant-derived chemotherapy drug) combined with androgen deprivation therapy (hormone therapy)
What this could lead to: If successful, this combination could become a new pre-surgery treatment option to improve outcomes for men with advanced or high-risk prostate cancer.
What could go wrong: This is a small, early-phase trial (Phase 2) with no control group, so results may not prove effectiveness. The drug can cause side effects like bone marrow suppression and heart rhythm 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 93 people

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

Started

Apr 2025

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 Aged ≥ 18 years and ≤ 85 years; * Histologically or cytologically confirmed prostate cancer; * Patients meeting any of the following disease staging criteria: 1. Localized high-risk/very high-risk prostate cancer: meeting at least one of the following characteristics (clinical stage T3-T4, Gleason score ≥ 8, primary Gleason pattern 5, or PSA \> 20 ng/mL), with no local lymph node metastasis (N0) and no distant metastasis (M0); 2. Prostate cancer with local lymph node metastasis: presence of local lymph node metastasis (N1) but no distant metastasis (M0); 3. Metastatic prostate cancer: confirmed as metastatic prostate cancer by imaging examinations; ④ Physical status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; ⑤ Informed consent: All patients voluntarily sign the informed consent form and can adhere to treatment and follow-up. Exclusion Criteria： ① Any previous or ongoing prostate cancer treatment, including radiotherapy, chemotherapy, androgen deprivation therapy (ADT), etc.; * A history of previous prostatectomy; * Any other severe underlying medical, psychiatric, or psychological diseases that, in the investigator's judgment, may affect the treatment; * A history of allergy to the drugs used in the study; ⑤ Refusal to undergo radical prostatectomy; ⑥ Ineligibility to participate in this clinical trial as judged by the investigator.

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Conditions

The condition(s) this trial relates to.

prostate cancer

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.

The places running it

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

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Could a traditional chinese medicine compound boost prostate cancer treatment?

What the study statuses mean