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

NCT ID: NCT06834321

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-19
• Study Completion Date: 2027-09-28

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).

Conditions

Prostate CA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Homoharringtonine combined with androgen deprivation treatment group

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).

Group Type: EXPERIMENTAL

Homoharringtonine combined with androgen deprivation therapy

Intervention Type: 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.

radical prostatectomy

Intervention Type: PROCEDURE

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

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).

Group Type: PLACEBO_COMPARATOR

Placebo combined with androgen deprivation treatment group

Intervention Type: 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.

radical prostatectomy

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DRUG

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,placebo is 5% glucose injection.

Intervention Type: DRUG

radical prostatectomy

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

Intervention Type: PROCEDURE

Other Intervention Names

drug intervention; drug intervention; surgical intervention

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The First People Hospital of Nantong City

UNKNOWN

Sponsor Role: collaborator

baotai Liang

OTHER

Sponsor Role: lead

Responsible Party

baotai Liang

resident doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Vice President of Zhongda Hospital

Role: STUDY_DIRECTOR

Zhongda Hospital

Locations

Zhongda Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

The First People Hospital of Nantong City

Nantong, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

resident doctor

Role: CONTACT

2978793353@qq.com

China+18852069821

Facility Contacts

resident doctor

Role: primary

2978793353@qq.com

中国+1885069821

resident doctor

Role: primary

871427347@qq.com

18706297061

Other Identifiers

2024ZDSYLL510-P01

Identifier Type: -

Identifier Source: org_study_id