RecruitingPhase 2Phase 3NCT06861192

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

Sponsor

baotai Liang

Enrollment

83 participants

Start Date

Feb 16, 2025

Study Type

INTERVENTIONAL

Conditions

Prostate CA

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

Sex: MALEMin Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination approach — a drug called fasudil hydrochloride plus an immunotherapy (PD-1 inhibitor) alongside standard hormone-blocking therapy — to treat prostate cancer before surgery (neoadjuvant therapy). **You may be eligible if...** - You are between 18 and 85 years old - You have a confirmed diagnosis of prostate cancer (not small cell type) - You have either locally advanced (cT3–4 stage) or metastatic cancer with 5 or fewer spread sites (bone or lymph nodes) - You have not received any prior prostate cancer treatment - You are willing to undergo radical prostatectomy (surgical removal of the prostate) **You may NOT be eligible if...** - You have had prior radiation, chemotherapy, hormone therapy, or prostate surgery - You have allergies to the drugs in this study - You have serious medical, mental, or psychological conditions that would interfere with treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFasudil 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

DRUGPlacebo 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.

PROCEDUREradical prostatectomy

Radical prostatectomy was performed 3 weeks (±7 days) after the treatment cycle