Neoadjuvant homoharringtonine with hormone therapy before prostatectomy

A Randomized Controlled Study of Homoharringtonine Combined With Androgen Deprivation in Neoadjuvant Therapy for Prostate Cancer

This will test whether adding homoharringtonine to standard androgen-deprivation therapy before prostatectomy helps men with locally advanced or oligometastatic prostate cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 85 Years
• Sex: Male
• Sponsor: Zhongda Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Nanjing, Jiangsu and 1 other locations)
• Trial ID: NCT06834321 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled phase 2 trial enrolls patients with locally advanced (cT3-4) or oligometastatic (≤5 metastases) prostate cancer who have not received prior prostate cancer treatment. Participants receive two cycles of intravenous homoharringtonine (1 mg on two consecutive days) or matched placebo, combined with continuous androgen-deprivation therapy, followed by imaging and radical prostatectomy about three weeks after treatment completion. Outcomes include PSA changes, imaging response, and pathological endpoints such as pathological complete response (pCR) and minimal residual disease (MRD), with routine follow-up every treatment cycle. The trial is conducted at hospitals in Jiangsu province with centralized follow-up and surgical management.

Who should consider this trial

Good fit: Men aged 18–85 with histologically confirmed prostate cancer that is locally advanced (cT3-4) or oligometastatic (≤5 bone or lymph node metastases), ECOG 0–1, no prior prostate cancer therapy, and willing to undergo radical prostatectomy are eligible.

Not a fit: Patients with prior prostate cancer treatment, small cell histology, significant comorbidities or allergies to the study drug, or those who refuse prostatectomy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If effective, this approach could increase pathological response rates and reduce residual tumor burden before surgery, potentially improving surgical outcomes.

How similar studies have performed: Neoadjuvant androgen-deprivation has produced mixed results for PSA and pCR in prior work, and the use of homoharringtonine in prostate cancer is largely novel with little published evidence supporting benefit.

Eligibility criteria

Inclusion Criteria:

* ① Age ≥18 years and ≤85 years;

  * Histologically confirmed prostate cancer without small cell features;

    * Metastatic prostate cancer was identified by imaging examination with ≤5 oligometastases (bone or lymph node metastases) or cT3-4 stages; ④The score of ECOG (Eastern Cooperative Oncology Group) was 0-1; ⑤ All patients voluntarily sign informed consent, and can adhere to treatment and follow-up;

Exclusion Criteria:

* ①Any previous or ongoing PCa treatment, including radiotherapy, chemotherapy, ADT, etc.

  * Previous prostatectomy;

    * Any other serious basic medical, mental, psychological, and other diseases that, in the judgment of the investigator, may affect the treatment of the patient

      * Allergic to the drugs used; ⑤ Refuse to undergo radical prostatectomy; ⑥ According to the investigator's judgment, it is not suitable to participate in this clinical trial;

Where this trial is running

Nanjing, Jiangsu and 1 other locations

• Zhongda Hospital — Nanjing, Jiangsu, China (Recruiting)
• The First People Hospital of Nantong City — Nantong, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: resident doctor

Conditions Prostate CA