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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate CA
• Intervention / Treatment: Drug: Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapy; Procedure: radical prostatectomy; Drug: Placebo combined with androgen deprivation therapy

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).

• Study Type: Interventional
• Enrollment (Estimated): 83
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: resident doctor; Phone Number: China+18852069821; Email: 2978793353@qq.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Zhongda Hospital
      • Contact: resident doctor; Phone Number: 中国+1885069821; Email: 2978793353@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 ≤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 Criteria:

• 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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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; Procedure: radical prostatectomy; 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.	Procedure: radical prostatectomy; Radical prostatectomy was performed 3 weeks (±7 days) after the treatment cycle; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCR or MRD rate	pCR (pathological complete response) is defined as cancer that is not morphologically recognizable in a prostatectomy specimen; MRD (small residual lesion) was defined as the maximum cross-section size of the residual tumor ≤5 mm, and RCB (residual cancer load) ≤ 0.25cm3 (tumor volume ≤ 0.5cm3 × tumor cells ≤ 50%) was used to calculate the tumor volume through three-dimensional volume estimation according to the maximum cross-section size and number of cross-sections involved in the tumor. Correction of tumor cell structure;	up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
PSA level change	At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Pathologic responses after radical prostatectomy (including positive surgical margin, tumor size, prostatic extension, seminal vesicle infiltration, and lymph node involvement)	up to 4 weeks
Biochemical progression-free survival after radical prostatectomy	The evaluation period was up to 1 year ( from the date of completion of surgery to the date of first recorded psa progression)

Collaborators and Investigators

• Sponsor: baotai Liang
• Investigators: Study Director: Vice President of Zhongda Hospital, Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2025
• Primary Completion (Estimated): March 16, 2026
• Study Completion (Estimated): March 16, 2027

Study Registration Dates

• First Submitted: March 2, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): November 18, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Pharmacologic Actions; Chemical Actions and Uses; Androgen Antagonists; fasudil
• Other Study ID Numbers: 2024ZDSYLL511-Y01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No