Status:
RECRUITING
Homoharringtonine Plus Androgen Deprivation Therapy in the Neoadjuvant Treatment of Prostate Cancer: A Single-Arm Clinical Study
Lead Sponsor:
baotai Liang
Collaborating Sponsors:
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Subei People's Hospital of Jiangsu Province
Conditions:
Prostate Cancer
Eligibility:
MALE
18-85 years
Phase:
PHASE2
Brief 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-m...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2027
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT07163910
Start Date
April 20 2025
End Date
December 20 2027
Last Update
November 18 2025
Active Locations (1)
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1
Zhongda Hospital
Nanjing, Jiangsu, China, 210009