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

NCT06861192 | Recruiting Phase 2

• 1 other identifier: 2024ZDSYLL511-Y01
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate CA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• PSA level change

  At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)

• 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)

• Pathologic responses after radical prostatectomy (including positive surgical margin, tumor size, prostatic extension, seminal vesicle infiltration, and lymph node involvement)

  up to 4 weeks

Study Arms (2)

Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation treatment group

EXPERIMENTAL

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; Procedure: radical prostatectomy

Placebo combined with androgen deprivation treatment group

PLACEBO COMPARATOR

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.

Drug: Placebo combined with androgen deprivation therapy; Procedure: radical prostatectomy

Interventions

Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation therapy DRUG

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

Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation treatment group

Placebo combined with androgen deprivation therapy DRUG

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.

Placebo combined with androgen deprivation treatment group

radical prostatectomy PROCEDURE

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

Fasudil hydrochloride and PD1 inhibitor combined with androgen deprivation treatment group; Placebo combined with androgen deprivation treatment group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• baotai Liang: lead

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Interventions

fasudil; Androgen Antagonists

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Vice President of Zhongda Hospital

  Zhongda Hospital

  STUDY DIRECTOR

Central Study Contacts

resident doctor

CONTACT

China+18852069821; 2978793353@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident doctor

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 6, 2025
• Study Start: February 16, 2025
• Primary Completion: March 16, 2026
• Study Completion (Estimated): March 16, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)