Neoadjuvant homoharringtonine with hormone therapy before prostatectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: resident doctor
• Email: 2978793353@qq.com
• Phone: China+18852069821

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.