RecruitingPhase 2NCT06834321

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


Sponsor

baotai Liang

Enrollment

96 participants

Start Date

Mar 19, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding homoharringtonine (HHT), a plant-derived chemotherapy agent, to standard hormone-blocking therapy (androgen deprivation therapy) before surgery helps shrink prostate cancer tumors more effectively — a treatment approach called neoadjuvant therapy. **You may be eligible if...** - You are between 18 and 85 years old - You have prostate cancer confirmed by biopsy (not the small cell type) - Your cancer has spread to a small number of sites (up to 5 metastases in bone or lymph nodes) or is locally advanced (stage T3–T4) - You have a good performance status (ECOG 0 or 1) - You have not received any previous prostate cancer treatment **You may NOT be eligible if...** - You have had any prior prostate cancer treatment (radiation, hormone therapy, chemotherapy) - You have already had prostate surgery - You are allergic to any of the study drugs - You have serious other medical or mental health conditions that could affect treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHomoharringtonine 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.

DRUGPlacebo 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.

PROCEDUREradical prostatectomy

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


Locations(2)

Zhongda Hospital

Nanjing, Jiangsu, China

The First People Hospital of Nantong City

Nantong, Jiangsu, China

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NCT06834321


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