Study of Fasudil Hydrochloride and PD1 Inhibitor With Androgen Deprivation Before Surgery for Locally Advanced or Oligometastatic Prostate Cancer

What this Trial Is About

The trial focuses on men with locally advanced or oligometastatic prostate cancer, conditions that pose significant health risks. Researchers aim to evaluate the effects of combining fasudil hydrochloride and a PD1 inhibitor with androgen deprivation therapy before radical prostatectomy. This randomized controlled study seeks to find more effective treatments for these stages of prostate cancer, addressing the limited improvements seen with standard androgen deprivation therapy alone. Participants are randomly assigned to one of two groups. The treatment group receives fasudil hydrochloride 10 mg daily on days 1 to 5 and PD-1 monoclonal antibody triprilizumab 3 mgkg intravenous drip on day 5, combined with routine androgen deprivation therapy. The control group receives matching placebo injections alongside androgen deprivation therapy. These treatments are repeated every 21 days for four cycles. Radical prostatectomy surgery is then performed about three weeks after completing the treatment cycles. Throughout the study, patients have regular follow-ups at the hospital during each treatment cycle to monitor blood PSA levels and other markers. Imaging tests are conducted after the treatment phase. The primary outcome measured is the rate of pathological complete response or minimal residual lesion within four weeks. Secondary outcomes include PSA level changes, biochemical progression-free survival up to one year post-surgery, and detailed pathological responses after prostatectomy. The total study participation spans from initial treatment through surgery and follow-up assessments.

Clinical Study of Fasudil Hydrochloride and PD1 Inhibitor Combined With Androgen Deprivation in Neoadjuvant Therapy of Prostate Cancer