About this trial
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 criteria
Qualifiers
Histologically or cytologically confirmed prostate cancer;
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- homoharringtonine
- Radical prostatectomy
Treatment groups
Sponsors and collaborators
baotai Liang
Lead sponsor
Zhongda Hospital
Sponsor institution
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Collaborator
Subei People's Hospital of Jiangsu Province
Collaborator
The First People Hospital of Nantong City
Collaborator