Homoharringtonine plus hormone therapy before prostate removal for high-risk prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm phase 2 study gives enrolled patients intravenous homoharringtonine together with continuous androgen deprivation therapy prior to radical prostatectomy. Homoharringtonine is administered as 1 mg IV with 250 ml 5% glucose once daily for two consecutive days per cycle, with localized/node-positive patients receiving at least one cycle and metastatic patients receiving at least three cycles on a repeated schedule. All participants undergo radical prostatectomy within about three weeks after completing neoadjuvant therapy. The trial aims to determine whether this combination can reduce tumor burden and improve surgical outcomes in advanced prostate cancer.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongda Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: resident doctor
• Email: 2978793353@qq.com
• Phone: 中国+1885069821

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.