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 fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation in patients with locally advanced prostate cancer or oligometastatic prostate cancer before radical prostatectomy through randomized controlled clinical trials, so as to find an effective treatment for locally advanced prostate cancer or oligometastatic prostate cancer.
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;
①Any previous or ongoing PCa treatment, including radiotherapy, chemotherapy, ADT, etc.
Previous prostatectomy;
Any other serious basic medical, mental, psychological, and other diseases that, in the judgment of the investigator, may affect the treatment of the patient
Allergic to the drugs used; ⑤ Refuse to undergo radical prostatectomy; ⑥ According to the investigator's judgment, it is not suitable to participate in this clinical trial;
Crossover
Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapy
DrugOn the 1st to 5th day, Fasudil hydrochloride (10mg of fasudil hydrochloride) was treated, and on the 5th day, PD-1 monoclonal antibody (triprilizumab, 3mg/kg, intravenous drip) was treated. The treatment was repeated every 21 days for a total of 4 times
Placebo combined with androgen deprivation therapy
DrugDays 1 to 5 were treated with placebo (0.9% sodium chloride 10mg), and days 5 were treated with placebo (0.9% sodium chloride 3mg/kg). The treatment was repeated every 21 days for a total of 4 times.
radical prostatectomy
Procedure/SurgeryRadical prostatectomy was performed 3 weeks (±7 days) after the treatment cycle
pCR or MRD rate
pCR (pathological complete response) is defined as cancer that is not morphologically recognizable in a prostatectomy specimen; MRD (small residual lesion) was defined as the maximum cross-section size of the residual tumor ≤5 mm, and RCB (residual cancer load) ≤ 0.25cm3 (tumor volume ≤ 0.5cm3 × tumor cells ≤ 50%) was used to calculate the tumor volume through three-dimensional volume estimation according to the maximum cross-section size and number of cross-sections involved in the tumor. Correction of tumor cell structure;
PSA level change
Biochemical progression-free survival after radical prostatectomy
Pathologic responses after radical prostatectomy (including positive surgical margin, tumor size, prostatic extension, seminal vesicle infiltration, and lymph node involvement)
Click on the lead sponsor to view all of their trials.
baotai Liang
Lead sponsor
Zhongda Hospital
Sponsor institution
