Study of Homoharringtonine Plus Androgen Deprivation Before Surgery in Men With Locally Advanced or Oligometastatic Prostate Cancer

What this Trial Is About

Researchers are evaluating the effects of homoharringtonine combined with androgen deprivation therapy in men with locally advanced or oligometastatic prostate cancer. The study aims to determine if this combination before radical prostatectomy can improve treatment outcomes compared to placebo combined with androgen deprivation. This randomized controlled clinical trial focuses on finding a more effective neoadjuvant therapy for these prostate cancer patients. Participants are randomly assigned to one of two groups the treatment group receives homoharringtonine 1mg by intravenous infusion along with 250ml of 5% glucose once daily for two consecutive days, repeated after three weeks, totaling two cycles, plus continuous androgen deprivation therapy. The placebo group receives a similar intravenous infusion of 5% glucose without homoharringtonine, also combined with continuous androgen deprivation therapy. Radical prostatectomy is performed about three weeks after completing the treatment cycles. During the study, patients are followed up every treatment cycle at the hospital to monitor blood PSA levels and other indicators. Imaging examinations are conducted at the end of treatment cycles, and the primary outcome measured is the rate of pathological complete response or minimal residual disease within four weeks. Secondary outcomes include changes in PSA levels after each treatment cycle, biochemical progression-free survival up to one year after surgery, and pathological responses following radical prostatectomy. The total study duration includes treatment, surgery, and follow-up assessments.

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