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

Last updated: November 17, 2025
Sponsor: baotai Liang
Overall Status: Active - Recruiting

Phase

2/3

Condition

Prostate Cancer, Early, Recurrent

Prostate Cancer

Prostate Disorders

Treatment

Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapy

radical prostatectomy

Placebo combined with androgen deprivation therapy

Clinical Study ID

NCT06861192
2024ZDSYLL511-Y01
  • Ages 18-85
  • Male

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • ① Age ≥18 years and ≤85 years;

  • Histologically confirmed prostate cancer without small cell features;

  • Metastatic prostate cancer was identified by imaging examination with ≤5oligometastases (bone or lymph node metastases) or cT3-4 stages; ④Thescore of ECOG (Eastern Cooperative Oncology Group) was 0-1; ⑤ All patientsvoluntarily sign informed consent, and can adhere to treatment andfollow-up;

Exclusion

Exclusion Criteria:

  • ①Any previous or ongoing PCa treatment, including radiotherapy, chemotherapy, ADT,etc.

  • Previous prostatectomy;

  • Any other serious basic medical, mental, psychological, and other diseasesthat, in the judgment of the investigator, may affect the treatment of thepatient

  • Allergic to the drugs used; ⑤ Refuse to undergo radicalprostatectomy; ⑥ According to the investigator's judgment, it is notsuitable to participate in this clinical trial;

Study Design

Total Participants: 83
Treatment Group(s): 3
Primary Treatment: Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapy
Phase: 2/3
Study Start date:
February 16, 2025
Estimated Completion Date:
March 16, 2027

Study 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).

Connect with a study center

  • Zhongda Hospital

    Nanjing 1799962, Jiangsu 1806260
    China

    Active - Recruiting

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