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

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Zhongda Hospital
  Nanjing, China Recruiting

Study contacts

• Study coordinator: baotai liang 梁
• Email: 2978793353@qq.com
• Phone: 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.