prostate cancer
Conditions
Interventions
experimental group:Patients with locally advanced hormone-sensitive prostate cancer receive oral darolutamide at a dose of 600 mg twice daily in combination with androgen deprivation therapy (ADT). Pa
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.>=18-year-old male; 2. Histopathologically confirmed prostate acinar adenocarcinoma with or without symptoms, with neuroendocrine differentiation component 1.5*10^9/L; 2) hemoglobin count (HGB) > 90 g/L; 3) Platelet count (PLT) >100*10^9/L; (2) Blood biochemistry (liver and kidney function) 1) Serum creatinine 30 g/L; 3) Total bilirubin (TBIL) <=1.5*ULN; 4) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=1.5*ULN; 9. Life expectancy of more than 2 years; 10. Able to provide written informed consent (ICF) and able to understand and agree to comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: Patients with any of the following will not be included in this study: 1. Visceral or brain metastases; 2. Any major surgery requiring general anesthesia within = 500 IU/mL (2500 copies/mL) of chronic hepatitis B virus carriers (HBV DNA testing is performed only for patients who test positive for hepatitis B surface antigen or core antibody); 9. Patients with positive HCV RNA test (HCV RNA test is only performed for patients with positive hepatitis C virus antibody); 10. Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism), or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or patients who have been using hormones or other immunomodulators in large quantities for a long time, or patients who are considered by other investigators to have an impact on the study treatment; 11. Have an active infection; 12. Presence of inability to swallow, chronic diarrhea, intestinal obstruction, or other factors affecting drug taking and absorption; 13. Known human immunodeficiency virus (HIV) infection; 14. Has an underlying medical condition or alcohol/drug abuse or dependence that is detrimental to the administration of the study drug, or that may affect the interpretation of results, or that results in the patient being at high risk of developing treatment complications; 15. Concurrent participation in another therapeutic clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission (pCR) rate;Minimal residual disease (MRD) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor volume;PSA value;Objective response rate;Biological recurrence (BCR);Radiological progression-free survival (rPFS);Tumor shrinkage ratio;Surgical margin positivity rate;Pathological downgrading; | — |
Countries
China
Contacts
Public ContactDi Gu
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed