NCT06861192

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

A Randomized Controlled Study of Fasudil Hydrochloride and PD1 Inhibitor Combined With Androgen Deprivation in Neoadjuvant Therapy for Prostate Cancer

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 83 (estimated)
• Sponsor: baotai Liang · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 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.

Detailed description

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).

Conditions

• Prostate CA

Interventions

Type	Name	Description
DRUG	Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapy	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
DRUG	Placebo combined with androgen deprivation therapy	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.
PROCEDURE	radical prostatectomy	Radical prostatectomy was performed 3 weeks (±7 days) after the treatment cycle

Timeline

• Start date: 2025-02-16
• Primary completion: 2026-03-16
• Completion: 2027-03-16
• First posted: 2025-03-06
• Last updated: 2025-11-18

Locations

1 site across 1 country: China