Fasudil plus PD-1 immunotherapy for metastatic castration-resistant prostate cancer

A Clinical Study on the Efficacy and Safety of Fasudil Hydrochloride Combined With Immunotherapy in the Treatment of Metastatic Castration-resistant Prostate Cancer

This Phase 2 trial will test whether adding fasudil hydrochloride to a PD-1 immunotherapy helps men with metastatic castration-resistant prostate cancer who have progressed after docetaxel and novel hormonal therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 85 Years
• Sex: Male
• Sponsor: Zhongda Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Nanjing)
• Trial ID: NCT07250542 on ClinicalTrials.gov

What this trial studies

This single-arm Phase 2 trial enrolls patients with metastatic castration-resistant prostate cancer who have failed at least one docetaxel-containing chemotherapy regimen and one standard novel endocrine therapy. Participants continue routine androgen-deprivation therapy and receive fasudil hydrochloride 10 mg IV on days 1–5 plus a PD-1 monoclonal antibody (Tirapibep) 3 mg/kg IV on day 5, repeated every 21 days for four cycles. The trial will monitor safety, PSA changes, and radiographic response during and after treatment. Findings will indicate tolerability and any early signs of anti-tumor activity for this combination.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–84 with metastatic castration-resistant prostate cancer, castrate testosterone <50 ng/ml, rising PSA or radiographic progression despite prior docetaxel and at least one novel endocrine therapy, measurable disease or bone metastases, and an expected survival of ≥3 months.

Not a fit: Patients with severe cardiovascular or cerebrovascular disease, significant liver dysfunction, or other major comorbidities excluded by the protocol are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the combination could provide a new option that slows disease progression or reduces tumor burden in patients with advanced, treatment-resistant prostate cancer.

How similar studies have performed: PD-1 drugs have shown limited benefit as single agents in unselected metastatic castration-resistant prostate cancer, and combining immune therapy with agents like fasudil remains experimental with mainly early-phase or preclinical support.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years and \< 85 years;
2. Patients who have failed at least one chemotherapy regimen containing docetaxel and one standard novel endocrine therapy;
3. Diagnosed with CRPC, defined as: after continuous castration therapy, the castration level of testosterone is \< 50 ng/ml; disease progression within 12 weeks before enrollment: PSA levels increase consecutively for 3 times at intervals of 1 week, and serum PSA ≥ 2 ng/ml; evaluated as soft tissue progression according to RECIST criteria, or ≥ 2 new lesions on bone scan;
4. Imaging evidence indicates bone metastatic disease and/or measurable non-bone metastatic disease (lymph nodes or internal organs); Expected survival period ≥ 3 months; All patients voluntarily signed the informed consent form and were able to cooperate with treatment and follow-up;

Exclusion Criteria:

1. Severe cardiovascular and cerebrovascular diseases;
2. Abnormal liver function: Total bilirubin in blood is less than 1.5 times the upper limit of normal value, and the ratio of blood ALT to AST is less than 2 times the upper limit of normal value;
3. Abnormal kidney function: Serum creatinine is less than 1.5 mg/dl or the creatinine clearance rate is greater than or equal to 60 cc/min;
4. Those allergic to the used drugs;
5. Those with tumors in other parts;
6. Abnormal thyroid function: Blood FT4 and/or TT4 levels are higher or lower than the normal value (normal blood FT4 level is 9-25 pmol/L (0.7-1.9 ng/dl), normal blood TT4 level is 64-154 nmol/L (5-12 ug/dl));
7. Cortisol deficiency: Serum cortisol at 8 a.m. is less than 140 nmol/L (5 ug/dL).

Where this trial is running

Nanjing

• Zhongda Hospital — Nanjing, China (Recruiting)

Study contacts

• Study coordinator: baotai liang 梁

Conditions Prostate Cancer