Clinical Study of Homoharringtonine Combined With Androgen Deprivation Therapy in Neoadjuvant Treatment of Prostate Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Zhongda Hospital
RECRUITING
Nanjing
Contact Information
Primary
resident doctor
2978793353@qq.com
中国+1885069821
Time Frame
Start Date: 2025-04-20
Estimated Completion Date: 2027-12-20
Participants
Target number of participants: 93
Treatments
Experimental: Patients with Localized High-Risk/Very High-Risk and Regional Lymph Node-Metastatic Prostate Cancer
This study is a single-arm clinical trial, and eligible patients will be enrolled. For the enrolled patients, the treatment regimen will consist of intravenous infusion of 1mg homoharringtonine combined with 250ml of 5% glucose injection, administered once daily for two consecutive days. Patients with localized high-risk/very high-risk prostate cancer or prostate cancer with local lymph node metastasis will receive at least one cycle of the above treatment plus continuous androgen deprivation therapy.All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the completion of treatment.
Experimental: Patients with metastatic prostate cancer
This study is a single-arm clinical trial, and eligible patients will be enrolled. For the enrolled patients, the treatment will consist of intravenous infusion of 1mg homoharringtonine plus 250ml of 5% glucose injection, administered once daily for two consecutive days. For patients with metastatic prostate cancer, the medication will be repeated after an interval of three weeks following one treatment cycle, with the entire course lasting for at least three cycles, in addition to continuous androgen deprivation therapy. All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the completion of treatment.
Related Therapeutic Areas
Sponsors
Collaborators: The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, Subei People's Hospital of Jiangsu Province, The First People Hospital of Nantong City
Leads: baotai Liang

This content was sourced from clinicaltrials.gov