Fasudil plus PD-1 antibody with androgen-deprivation therapy before prostatectomy.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled trial enrolls men with locally advanced or oligometastatic prostate cancer who are scheduled for radical prostatectomy. Participants receive standard androgen-deprivation therapy and are randomized to receive either fasudil plus a PD-1 monoclonal antibody (triprilizumab 3 mg/kg IV on day 5 with fasudil 10 mg on days 1–5) or matching placebo. Patients are followed each treatment cycle with PSA and other laboratory tests, undergo imaging at the end of treatment, and proceed to radical prostatectomy about three weeks after the final intervention. The study focuses on pathological response (pCR and minimal residual disease) and preoperative PSA/imaging changes to see if the combination improves tumor control before surgery.

Why it matters

Who can join: the full rules

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;

Where it's running

• Zhongda Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: resident doctor
• Email: 2978793353@qq.com
• Phone: China+18852069821

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.