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
baotai Liang
83 participants
Feb 16, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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;
Exclusion Criteria4
- 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;
Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06861192