Overview
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.
Description
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.
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:
- 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.;
- Patients meeting any of the following disease staging criteria:
- 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.
- Any other severe underlying medical, psychiatric, or psychological diseases that, in the investigator's judgment, may affect the treatment;