Exploratory Study on the Efficacy and Safety of Triple Therapy (ADT + Darolutamide + Docetaxel Chemotherapy) Combined With Transrectal High-Intensity Focused Ultrasound Focal Therapy in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) With High Tumor Burden
This study is a single-arm prospective cohort study designed to evaluate the efficacy and safety of triple therapy (ADT + darolutamide + docetaxel) combined with transrectal high-intensity focused ultrasound (HIFU) focal therapy in patients with high-tumor-burden metastatic hormone-sensitive prostate cancer (mHSPC). A total of 116 high-tumor-burden mHSPC patients will be enrolled and are scheduled to receive the following treatment: Darolutamide + Docetaxel + ADT + Transrectal HIFU Focal Therapy for the Prostate.
• Patients who agree to participate in the study and sign the informed consent form.
• Age ≥18 years, male.
• Histologically or cytologically confirmed prostate adenocarcinoma.
• Bone scan, CT, or MRI showing ≥4 bone metastases (with ≥1 outside the pelvis or spine) or visceral metastases.
• Newly diagnosed or recurrent disease after local therapy, with sensitivity to androgen deprivation therapy (ADT).
• Patients who have received ADT (medical or surgical castration) with or without first-generation antiandrogens for ≤3 months, without evidence of soft tissue disease progression (per RECIST 1.1) or clinically significant PSA progression (≥50% increase from nadir with serum testosterone at castrate levels).
• Planned treatment with docetaxel plus apalutamide and ADT, or apalutamide plus ADT.
• ECOG Performance Status (PS) score of 0-1.
• Adequate hematologic and organ function:
‣ \*\*Bone marrow function (without transfusion or growth factor support):\*\*
⁃ Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (1500/μL)
⁃ Hemoglobin ≥90 g/L (9.0 g/dL)
⁃ Platelet count ≥100 × 10⁹/L (100,000/μL)
⁃ \*\*Liver function:\*\*
⁃ Total bilirubin (TBIL) ≤1.5 × ULN
⁃ AST, ALT, and alkaline phosphatase (ALP) ≤2.5 × ULN
⁃ \*\*Renal function:\*\*
⁃ Serum creatinine ≤1.5 × ULN \*\*or\*\* calculated creatinine clearance ≥30 mL/min (Cockcroft-Gault formula)
⁃ \*\*Coagulation function (without anticoagulation therapy):\*\* INR ≤1.5
⁃ Patients of reproductive potential must use effective contraception during the study and for 6 months after the last dose.