Homoharringtonine plus hormone therapy before prostate removal for high-risk prostate cancer

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

This study tests whether adding homoharringtonine to standard hormone therapy before prostate removal helps men with high-risk, node-positive, or metastatic prostate cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (estimated)
• Ages: 18 Years to 85 Years
• Sex: Male
• Sponsor: Zhongda Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07163910 on ClinicalTrials.gov

What this trial studies

This single-arm phase 2 study gives enrolled patients intravenous homoharringtonine together with continuous androgen deprivation therapy prior to radical prostatectomy. Homoharringtonine is administered as 1 mg IV with 250 ml 5% glucose once daily for two consecutive days per cycle, with localized/node-positive patients receiving at least one cycle and metastatic patients receiving at least three cycles on a repeated schedule. All participants undergo radical prostatectomy within about three weeks after completing neoadjuvant therapy. The trial aims to determine whether this combination can reduce tumor burden and improve surgical outcomes in advanced prostate cancer.

Who should consider this trial

Good fit: Ideal candidates are men aged 18–85 with histologically confirmed prostate cancer who have localized high/very-high-risk disease, regional lymph node metastasis, or imaging-confirmed metastatic disease and an ECOG performance status of 0–1.

Not a fit: Patients who have received prior prostate cancer treatment or who have poor performance status or significant comorbidities are unlikely to benefit from this neoadjuvant approach.

Why it matters

Potential benefit: If successful, the regimen could shrink tumors before surgery and increase the likelihood of complete tumor removal for men with advanced prostate cancer.

How similar studies have performed: Using homoharringtonine in prostate cancer is relatively novel and there is limited prior clinical evidence supporting this specific neoadjuvant combination.

Eligibility criteria

Inclusion Criteria：

① Aged ≥ 18 years and ≤ 85 years;

* Histologically or cytologically confirmed prostate cancer;

  * Patients meeting any of the following disease staging criteria:

    1. 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);
    2. Prostate cancer with local lymph node metastasis: presence of local lymph node metastasis (N1) but no distant metastasis (M0);
    3. 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.

Where this trial is running

Nanjing, Jiangsu

• Zhongda Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: resident doctor

Conditions Prostate Cancer