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

NCT06834321 | Recruiting Phase 2

• 1 other identifier: 2024ZDSYLL510-P01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate CA

Outcome Measures

Primary Outcomes (1)

• pCR or MRD rate

  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;

  up to 4 weeks

Secondary Outcomes (3)

• PSA level change

  At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)

• 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

Study Arms (2)

Homoharringtonine combined with androgen deprivation treatment group

EXPERIMENTAL

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).

Drug: Homoharringtonine combined with androgen deprivation therapy; Procedure: radical prostatectomy

Placebo combined with androgen deprivation treatment group

PLACEBO COMPARATOR

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).

Drug: Placebo combined with androgen deprivation treatment group; Procedure: radical prostatectomy

Interventions

Homoharringtonine combined with androgen deprivation therapy DRUG

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.

Also known as: drug intervention

Homoharringtonine combined with androgen deprivation treatment group

Placebo combined with androgen deprivation treatment group DRUG

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,placebo is 5% glucose injection.

Also known as: drug intervention

Placebo combined with androgen deprivation treatment group

radical prostatectomy PROCEDURE

Radical prostatectomy was performed 3 weeks (±7 days) after the treatment cycle.

Also known as: surgical intervention

Homoharringtonine combined with androgen deprivation treatment group; Placebo combined with androgen deprivation treatment group

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 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• baotai Liang: lead
• The First People Hospital of Nantong City: collaborator

Study Sites (2)

Zhongda Hospital

Nanjing, Jiangsu, China

RECRUITING

The First People Hospital of Nantong City

Nantong, Jiangsu, China

RECRUITING

MeSH Terms

Interventions

Androgen Antagonists; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Vice President of Zhongda Hospital

  Zhongda Hospital

  STUDY DIRECTOR

Central Study Contacts

resident doctor

CONTACT

China+18852069821; 2978793353@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 19, 2025
• Study Start: March 19, 2025
• Primary Completion (Estimated): September 28, 2026
• Study Completion (Estimated): September 28, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)