Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 85Years
MALE
NCT06861192

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

Led by baotai Liang · Updated on 2025-11-18

83

Participants Needed

1

Research Sites

108 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 85Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 85 years
  • Histologically confirmed prostate cancer without small cell features
  • Locally advanced prostate cancer (cT3-4) or oligometastatic prostate cancer with 5 or fewer bone or lymph node metastases
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Ability and willingness to provide informed consent and adhere to treatment and follow-up
Not Eligible

You will not qualify if you...

  • Previous or ongoing prostate cancer treatments including radiotherapy, chemotherapy, androgen deprivation therapy, or prostatectomy
  • Presence of any serious medical, mental, or psychological condition that could affect treatment
  • Allergy to study drugs
  • Refusal to undergo radical prostatectomy
  • Investigator's judgment deeming unsuitability for the clinical trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhongda Hospital

Nanjing, Jiangsu, China

Actively Recruiting

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Research Team

R

resident doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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