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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Zhongda Hospital
RECRUITING
Nanjing
The First People Hospital of Nantong City
RECRUITING
Nantong
Contact Information
Primary
resident doctor
2978793353@qq.com
China+18852069821
Time Frame
Start Date: 2025-03-19
Estimated Completion Date: 2027-09-28
Participants
Target number of participants: 96
Treatments
Experimental: 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).
Placebo_comparator: 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).
Related Therapeutic Areas
Sponsors
Leads: baotai Liang
Collaborators: The First People Hospital of Nantong City

This content was sourced from clinicaltrials.gov