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

NCT07163910 | Recruiting Phase 2

• 1 other identifier: 2024ZDSYLL510-P02
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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-metastatic, or metastatic prostate cancer before radical prostatectomy through clinical trials, thereby identifying an effective treatment for patients with advanced prostate cancer.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• pCR or MRD rate

  Within three weeks after the operation

• PSA response rate

  Within one week after the completion of the last treatment cycle (each treatment cycle lasts approximately 25 days)

• Biochemical Progression-Free Survival (bPFS) after radical prostatectomy

  From the date of random grouping to the date when progression was first recorded or the date of any cause of death (whichever comes first), an assessment was conducted for a period of up to 5 years.

Secondary Outcomes (5)

• Pathological response after radical prostatectomy (including positive surgical margins, tumor size, extraprostatic extension, seminal vesicle invasion, and lymph node involvement)

  Within one month after the surgery

• Changes in radiological TNM staging from post-neoadjuvant therapy to pre-surgery

  Within one month after the surgery

• Other progression-free survival (progression includes radiological progression, castration resistance, need for further therapeutic intervention, etc.)

  From the date of random grouping to the date when progression was first recorded or the date of any cause of death (whichever comes first), an assessment was conducted for a period of up to 5 years.

• Safety indicator: CTCAE 5.0 Adverse Event Grading

  From the date of random grouping to the date when progression was first recorded or the date of any cause of death, an assessment was conducted for a period of up to 5 years.

• Quality of life score: EORTC QLQ-C30 scale

  From the date of random grouping to the date when progression was first recorded or the date of any cause of death, an assessment was conducted for a period of up to 5 years.

Study Arms (2)

Patients with Localized High-Risk/Very High-Risk and Regional Lymph Node-Metastatic Prostate Cancer

EXPERIMENTAL

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.

Drug: homoharringtonine; Procedure: Radical prostatectomy

Patients with metastatic prostate cancer

EXPERIMENTAL

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.

Drug: homoharringtonine; Procedure: Radical prostatectomy

Interventions

homoharringtonine DRUG

Intravenous infusion of 1mg homoharringtonine plus 250ml of 5% glucose injection, administered once daily for two consecutive days.

Also known as: drug therapy

Patients with Localized High-Risk/Very High-Risk and Regional Lymph Node-Metastatic Prostate Cancer; Patients with metastatic prostate cancer

Radical prostatectomy PROCEDURE

All patients will undergo radical prostatectomy within 3 weeks (±7 days) after the completion of treatment.

Also known as: operative treatment

Patients with Localized High-Risk/Very High-Risk and Regional Lymph Node-Metastatic Prostate Cancer; Patients with metastatic prostate cancer

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• baotai Liang: lead
• 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

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Homoharringtonine; Drug Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Harringtonines; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings; Therapeutics

Study Officials

• Chief Physician

  Vice President of Zhongda Hospital Affiliated to Southeast University

  STUDY DIRECTOR

Central Study Contacts

resident doctor

CONTACT

中国+1885069821; 2978793353@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lead researcher

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 9, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): December 20, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)