NCT06834321

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: baotai Liang · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
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.
PROCEDURE	radical prostatectomy	Radical prostatectomy was performed 3 weeks (±7 days) after the treatment cycle.

Timeline

• Start date: 2025-03-19
• Primary completion: 2026-09-28
• Completion: 2027-09-28
• First posted: 2025-02-19
• Last updated: 2025-09-08

Locations

2 sites across 1 country: China