New hope for high-risk prostate cancer: drug duo after surgery may stop recurrence

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The patient volunteers to participate and signs the informed consent form (ICF); * Age 18-75 years (inclusive), male; * Histologically or cytologically confirmed prostatic adenocarcinoma; * No non-regional lymph-node metastasis, bone metastasis, or other distant metastasis (e.g., visceral) by conventional imaging (bone scan, CT or MRI) or by PET/CT; i.e., M0; * High-risk per the Briganti 2019 nomogram, i.e., risk \>7%; * PSA \<0.1 ng/mL at 6 weeks after radical prostatectomy (RP); * Has undergone RP without pelvic lymph-node dissection; * Not suitable for adjuvant/salvage radiotherapy (RT) after RP, or the patient declines RT; * Patients with lymph-node involvement (LNI) indicated by PSMA-PET who did not undergo extended pelvic lymph-node dissection (ePLND) may be enrolled; * Patients with negative intraoperative obturator lymph-node biopsy who did not undergo ePLND may be enrolled; * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1; * Adequate hematologic and organ function: * 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) (without transfusion and/or growth factors within 3 months prior to starting study treatment); * Serum potassium ≥3.5 mmol/L; * Total bilirubin (TBIL) ≤2.0 × ULN (for Gilbert syndrome, TBIL \>1.5 × ULN is not eligible; if indirect bilirubin ≤1.5 × ULN, enrollment is allowed); * AST and ALT ≤2.5 × ULN; * Serum albumin ≥30 g/L (3.0 g/dL); * Serum creatinine \<2 × ULN; * Patients of childbearing potential must agree to use effective contraception throughout the study and for 3 months after the last dose. Exclusion Criteria: * Histologic features of neuroendocrine differentiation or small-cell carcinoma; * Prior prostate cancer treatments including any of the following: * Systemic therapy, including but not limited to: \>2 months of ADT; \>2 months of conventional hormonal therapy (e.g., flutamide, bicalutamide); next-generation hormonal agents (e.g., darolutamide, abiraterone, apalutamide, enzalutamide, relugolix); chemotherapy (e.g., docetaxel); immunotherapy; targeted therapy; * Local radiotherapy; * Planned bilateral orchiectomy during the study treatment period; * Inability to tolerate darolutamide or ADT; * Concurrent participation in, or planned participation in, another clinical trial; * A malignancy other than prostate cancer within the past 5 years or concurrently, except for cured basal cell carcinoma of the skin; * Any concomitant disease or condition that, in the investigator's judgment, presents a serious risk to patient safety, may confound study results, or may interfere with completion of the study (e.g., severe cardiovascular disease, active infection, gastrointestinal disease, neurologic or psychiatric disorders, etc.); * Any other condition deemed by the investigator to make the patient unsuitable for this study.