patients with post-chemotherapy metastatic castration-resistant prostate cancer
Conditions
Interventions
Lukastuximab group:The administration dose of the study drug Sac-TMT was 4mg/kg, administered intravenously once every 2 weeks (D1, D15), with each cycle lasting 4 weeks.
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age requirement: Male, age >=18 years; 2. Life expectancy: Estimated survival >=3 months; 3. Alert, without intellectual or mental impairment, with normal language expression ability; 4. ECOG PS score: 0-2; 5. Patient has signed the informed consent form, has good compliance, and is able to cooperate with follow-up for efficacy and adverse events; 6. Prostate cancer status: Prior bilateral orchiectomy; for those who have not undergone bilateral orchiectomy, continuous androgen deprivation therapy (ADT) with gonadotropin-releasing hormone (GnRH) agonists/antagonists should have been previously administered, with serum testosterone at castrate level (=2 new bone lesions on CT/MRI or ECT; 8. Palliative radiotherapy for control of secondary symptoms of prostate cancer should have been completed at least 2 weeks before screening; 9. Adequate major organ function, meeting the following laboratory criteria: (1) Absolute neutrophil count (ANC) >=1.5×10^9/L without granulocyte colony-stimulating factor use in the past 14 days; (2) Platelet count >=90×10^9/L without blood transfusion in the past 14 days; (3) Hemoglobin >9 g/dL without blood transfusion in the past 14 days; (4) Total bilirubin =40 mL/min; (7) Cardiac function: Left ventricular ejection fraction (LVEF) >=50%.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of psychiatric disorders, epileptic seizures, or severe cognitive impairment are excluded. 2.Receiving monoamine oxidase inhibitors (MAOIs) that cannot be discontinued throughout the study period. 3.Definite bleeding tendency, e.g., active local ulcerative lesions with fecal occult blood (++). 4.Uncontrolled severe cardiovascular diseases, including heart failure, active angina pectoris, baseline QTc interval >450 ms on electrocardiogram (ECG), clinically significant arrhythmias (ventricular tachycardia, atrial fibrillation, atrioventricular block), or bradycardia (=160 mmHg or diastolic blood pressure >=100 mmHg during screening despite antihypertensive medication. 6.Severe active infection: Severe infection (CTCAE grade >2) occurring within 4 weeks prior to the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; or active pulmonary inflammation indicated by chest imaging. 7.History of active cerebrovascular disease or other arterial thromboembolic events within 6 months prior to screening. 8.Symptomatic central nervous system (CNS) metastases. 9.Histopathologically confirmed primary prostatic small cell carcinoma, prostatic ductal carcinoma or neuroendocrine carcinoma. 10.Presence of other malignancies requiring treatment. 11.Prior use of immune checkpoint inhibitors within 6 months before screening. 12.Prior exposure to antibody-drug conjugates (ADCs). 13.Patients with prior PARPi treatment and confirmed BRCA positivity or unknown BRCA status. 14.Concurrent participation in other clinical trials that may interfere with the evaluation of study outcomes. 15.Known hypersensitivity, allergy or intolerance to study drug or its excipients. 16.Other severe concomitant diseases deemed by the investigator to jeopardize patient safety or interfere with study completion. 17.Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disorders that impede or delay corneal healing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic progression-free survival (rPFS) assessed by the investigator; | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA response rate;Time to PSA progression;Time to symptomatic progression;The incidence and severity of adverse events (AE);Patient Reported Outcome; | — |
Countries
China
Contacts
Public ContactGong Liyan
Zhejiang Cancer Hospital
Outcome results
None listed