Clinical Study on Neoadjuvant Therapy of Homoharringtonine Combined With Androgen Deprivation for Prostate Cancer

Phase 2

• Conditions: Prostate CA
• Interventions: Drug: Homoharringtonine combined with androgen deprivation therapy; Drug: Placebo combined with androgen deprivation treatment group; Procedure: radical prostatectomy

• Registration Number: NCT06834321
• Lead Sponsor: baotai Liang

Brief Summary

The high incidence of prostate cancer is one of the important diseases that threaten the health of old men in our country. Although androgen deprivation therapy is an important treatment option for prostate cancer, although neoadjuvant androgen deprivation therapy combined with radical prostatectomy reduced the positive rate of surgical margins, it did not show statistically significant improvement in prostate-specific antigen (PSA). At the same time, few trials reported pathological complete response (pCR) and minimal residual lesion (MRD).

The purpose of this project is to verify the therapeutic effect of homoharringtonine combined androgen deprivation in patients with locally advanced prostate cancer or oligometastatic prostate cancer before radical prostatectomy through a randomized controlled clinical trial, so as to find an effective treatment for locally advanced prostate cancer or oligometastatic prostate cancer.

Detailed Description

This study will divide patients into two sections, and eligible patients will be enrolled. Patients with locally advanced prostate cancer or oligo-metastatic prostate cancer were divided into two groups, homoharringtonine combined with androgen deprivation and placebo combined with androgen deprivation, according to a computer-generated random sequence. Treatment group was given 1mg intravenous infusion of homoharringtonine + 250ml 5% glucose injection, once a day for two consecutive days, and repeated medication after three weeks of intermittent treatment for two cycles + continuous androgen deprivation therapy; In the placebo group, the same size, color, and dosage form of 5% glucose injection were used, and the administration was the same as in the treatment group. After starting the intervention, all patients should be followed up in our hospital every treatment cycle to review blood PSA and other indicators. At the end of the treatment cycle, imaging examinations were followed up and radical prostatectomy was performed 3 weeks later (±7 days).

Study Timeline

• Study Start: 2025-01-10
• Study First Submitted: 2025-02-12
• Study First Submitted QC: 2025-02-18
• Study First Posted: 2025-02-19
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-29
• Last Update Posted: 2025-09-02
• Primary Completion: 2026-09-28
• Study Completion: 2027-09-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 96

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Homoharringtonine combined with androgen deprivation treatment group	Homoharringtonine combined with androgen deprivation therapy	Homoharringtonine 1mg intravenous infusion +5% glucose injection 250ml intravenous infusion, once a day for two consecutive days, repeated administration after three weeks of intermittent treatment, lasting two cycles + continuous androgen deprivation therapy，radical prostatectomy was performed 3 weeks later (±7 days).
Homoharringtonine combined with androgen deprivation treatment group	radical prostatectomy	Homoharringtonine 1mg intravenous infusion +5% glucose injection 250ml intravenous infusion, once a day for two consecutive days, repeated administration after three weeks of intermittent treatment, lasting two cycles + continuous androgen deprivation therapy，radical prostatectomy was performed 3 weeks later (±7 days).
Placebo combined with androgen deprivation treatment group	Placebo combined with androgen deprivation treatment group	Placebo 1mg intravenous infusion +5% glucose injection 250ml intravenous infusion, once a day for two consecutive days, and repeated administration after a break of three weeks for two cycles + continuous androgen deprivation therapy，radical prostatectomy was performed 3 weeks later (±7 days).
Placebo combined with androgen deprivation treatment group	radical prostatectomy	Placebo 1mg intravenous infusion +5% glucose injection 250ml intravenous infusion, once a day for two consecutive days, and repeated administration after a break of three weeks for two cycles + continuous androgen deprivation therapy，radical prostatectomy was performed 3 weeks later (±7 days).

Primary Outcome Measures

Name	Time	Method
pCR or MRD rate	up to 4 weeks	pCR (pathological complete response) is defined as cancer that is not morphologically recognizable in a prostatectomy specimen; MRD (small residual lesion) was defined as the maximum cross-section size of the residual tumor ≤5 mm, and RCB (residual cancer load) ≤ 0.25cm3 (tumor volume ≤ 0.5cm3 × tumor cells ≤ 50%) was used to calculate the tumor volume through three-dimensional volume estimation according to the maximum cross-section size and number of cross-sections involved in the tumor. Correction of tumor cell structure;

Secondary Outcome Measures

Name	Time	Method
Biochemical progression-free survival after radical prostatectomy	The evaluation period was up to 1 year from the date of completion of surgery to the date of first recorded psa progression
Pathologic responses after radical prostatectomy (including positive surgical margin, tumor size, prostatic extension, seminal vesicle infiltration, and lymph node involvement)	up to 4 weeks
PSA level change	At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)

Trial Locations

Locations (1)

Zhongda Hospital; 🇨🇳 Nanjing, China