Fasudil plus PD-1 antibody with androgen-deprivation therapy before prostatectomy.
A Randomized Controlled Study of Fasudil Hydrochloride and PD1 Inhibitor Combined With Androgen Deprivation in Neoadjuvant Therapy for Prostate Cancer
This trial tests whether adding fasudil and a PD-1 antibody to standard hormone (androgen-deprivation) therapy before prostatectomy helps men with locally advanced or oligometastatic prostate cancer.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 83 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Male |
| Sponsor | Zhongda Hospital Academic / other |
| Drugs / interventions | chemotherapy, triprilizumab |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06861192 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men aged 18–85 with histologically confirmed prostate adenocarcinoma who are cT3-4 or have ≤5 oligometastatic lesions, have ECOG 0–1, have not received prior prostate cancer treatment, and agree to radical prostatectomy.
Not a fit: Patients who have received prior prostate cancer treatments, have small-cell histology, significant comorbidities or drug allergies, or who refuse prostatectomy are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the combination could increase complete pathological responses and reduce residual tumor before surgery, potentially improving surgical and long-term outcomes.
How similar studies have performed: Neoadjuvant PD-1 therapies have shown limited benefit in prostate cancer so far, and combining them with a Rho-kinase inhibitor like fasudil is largely novel with little prior clinical evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nanjing, Jiangsu
- Zhongda Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: resident doctor
- Email: 2978793353@qq.com
- Phone: China+18852069821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.