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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
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• 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;

Locations
Other Locations
China
Zhongda Hospital
RECRUITING
Nanjing
Contact Information
Primary
resident doctor
2978793353@qq.com
China+18852069821
Time Frame
Start Date: 2025-02-16
Estimated Completion Date: 2027-03-16
Participants
Target number of participants: 83
Treatments
Experimental: Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation treatment group
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.
Placebo_comparator: Placebo combined with androgen deprivation treatment group
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.
Related Therapeutic Areas
Sponsors
Leads: baotai Liang

This content was sourced from clinicaltrials.gov