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Clinical Study on Neoadjuvant Therapy of Homoharringtonine Combined With Androgen Deprivation for Prostate Cancer
Sponsor: baotai Liang
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.
Official title: A Randomized Controlled Study of Homoharringtonine Combined With Androgen Deprivation in Neoadjuvant Therapy for Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2025-03-19
Completion Date
2027-09-28
Last Updated
2025-09-08
Healthy Volunteers
No
Conditions
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.
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.
radical 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