A Phase 2/3 interventional study of Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapy and Placebo combined with androgen deprivation therapy in Prostate CA, sponsored by baotai Liang. Recruiting at 1 site in China. Open to male participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by baotai Liang · Phase 2/3, Interventional, and Treatment
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.
This study will divide patients into two sections, and eligible patients will be enrolled. Patients with locally advanced prostate cancer or oligometastatic prostate cancer were assigned to either fasudil hydrochloride and PD1 inhibitor combined androgen deprivation therapy or placebo combined androgen deprivation therapy based on a computer-generated random sequence. In addition to routine androgen deprivation therapy, patients in the treatment group were given 10mg of fasudil hydrochloride on the 1st to 5th day and PD-1 monoclonal antibody (triprilizumab, 3mg/kg, intravenous drip) on the 5th day. In the placebo group, the same size, color and dosage form of 0.9% sodium chloride injection was used, and the administration was the same as that in the treatment group. After starting the intervention, all patients should be followed up in our hospital every treatment cycle to review blood PSA and other indicators. At the end of the treatment cycle, imaging examinations were followed up and radical prostatectomy was performed 3 weeks later (±7 days).
baotai Liang is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
① Age ≥18 years and ≤85 years;
Histologically confirmed prostate cancer without small cell features;
Exclusion Criteria:
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
On 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.Radical prostatectomy was performed 3 weeks (±7 days) after the treatment cycle.
Drug: Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapy · Procedure: radical prostatectomy
Days 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 was performed 3 weeks (±7 days) after the treatment cycle.
Drug: Placebo combined with androgen deprivation therapy · Procedure: radical prostatectomy
On 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
Days 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 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;
Time frame: up to 4 weeks
PSA level change
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Biochemical progression-free survival after radical prostatectomy
Time frame: The evaluation period was up to 1 year ( from the date of completion of surgery to the date of first recorded psa progression)
Pathologic responses after radical prostatectomy (including positive surgical margin, tumor size, prostatic extension, seminal vesicle infiltration, and lymph node involvement)
Time frame: up to 4 weeks
Plan to share: No
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