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

This study is a single-arm clinical trial, and eligible patients will be enrolled. For the enrolled patients, they will receive an intravenous infusion of homoharringtonine (1 mg) plus an intravenous infusion of 5% glucose injection (250 ml), once daily for two consecutive days. Patients with localized high-risk/very high-risk and regional lymph node-metastatic prostate cancer will receive at least one cycle of the above treatment plus continuous androgen deprivation therapy; patients with metastatic prostate cancer will receive one cycle of treatment, followed by a three-week interval before repeated medication, with the treatment repeated for a total of at least three cycles plus continuous androgen deprivation therapy. All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the end of treatment.

Inclusion criteria

：

① Aged ≥ 18 years and ≤ 85 years;

• Histologically or cytologically confirmed prostate cancer;

• Patients meeting any of the following disease staging criteria:

• 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);
• Prostate cancer with local lymph node metastasis: presence of local lymph node metastasis (N1) but no distant metastasis (M0);
• 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.