prostate cancer
Conditions
Interventions
Experimental group:Darusartan 600 mg orally twice a day combined with ADT treatment, and doxorubicin perfusion chemotherapy of the prostate artery (45 mg/m2, 3 weeks once, a total of 6 cycles) within
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Male patients aged >=18 years; (2) Histopathologically confirmed adenocarcinoma of the prostate, with or without symptoms; (3) Primary tumor lesion not previously treated; (4) Evidence of distant metastasis (bone, visceral, etc.) with or without lymph node metastasis as shown by bone scan, CT, MRI, or PSMA PET/CT performed within 90 days prior to enrollment; (5) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; (6) Adequate organ function: a) Hematology (no transfusion within 7 days and no use of granulocyte colony-stimulating factor or similar drugs within 4 weeks before treatment) ? Neutrophil count (NE) >1.5*10^9/L; ? Hemoglobin level (HGB) >90 g/L; ? Platelet count (PLT) >100*10^9/L; b) Biochemistry (liver and kidney function) ? Serum creatinine 30 g/L; ? Total bilirubin (TBIL) <=1.5*ULN; ? Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=1.5*ULN; (7) Life expectancy of more than 2 years; (8) Able to provide written informed consent (ICF) and able to understand and agree to comply with study requirements.
Exclusion criteria
Exclusion criteria: (1) Major surgery requiring general anesthesia performed <=28 days before the first dose of the study drug; (2) Severe atherosclerosis, vascular tortuosity, coagulation disorders, or other conditions that preclude interventional therapy; (3) History or current diagnosis of another malignancy within the past 2 years; (4) Significant cardiovascular disease within 6 months prior to starting study treatment, including: severe/unstable angina, myocardial infarction, congestive heart failure [New York Heart Association (NYHA) Class III or worse], cerebrovascular accident, or arrhythmia requiring medication; (5) Allergy to any of the study drugs or excipients; (6) Any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or long-term use of high doses of steroids or other immunomodulatory agents, or other conditions assessed by the investigator that could impact the study treatment; (7) Active infection; (8) Inability to swallow, chronic diarrhea, bowel obstruction, or other factors affecting drug intake and absorption; (9) Underlying medical condition or alcohol/drug abuse or dependence that may adversely affect the administration of the study drug, interfere with result interpretation, or increase the risk of complications from treatment; (10) Concurrent participation in another therapeutic clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA response (PSA not detected, <0.2 ng/mL); | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiological Progression-Free Survival (rPFS);Imaging examination (PSMA-TV, TL-PSMA or bone imaging, CT, MRI, etc.);Visual analogue rating method;Quality of Life Score;International Prostate Symptom Score; | — |
Countries
China
Contacts
Public ContactDi Gu
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed