Homoharringtonine Plus Androgen Deprivation Therapy in the Neoadjuvant Treatment of Prostate Cancer: A Single-Arm Clinical Study

Summary

The project aims to verify the therapeutic effect of neoadjuvant homoharringtonine combined with androgen deprivation therapy in patients with localized high-risk/very high-risk, regional lymph node-metastatic, or metastatic prostate cancer before radical prostatectomy through clinical trials, thereby identifying an effective treatment for patients with advanced prostate cancer.

Eligibility

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.

Conditions2

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