A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer

Inclusion criteria

• Male ≥18 years of age.
• Able to Sign informed consent form independently.
• Non-metastatic adenocarcinoma of the prostate.
• Subjects must have as least one of the following features according to NCCN definition of high-risk: Gleason score ≥8, or PSA >20ng/ml,or≥clinical T3a.
• Subjects with pelvic lymph node involvement(N1) can be included.
• Candidate for radical prostatectomy with or without pelvic lymph node dissection as per the investigator.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• Subjects must have normal organ and marrow function as defined below:

Hemoglobin ≥ 9.0 g/dL;Absolute neutrophil count (ANC) ≥ 1,500/mcL; Platelets ≥ 100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start; Serum potassium ≥ 3.5 mmol/L; Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) (except in subjects with Gilbert's syndrome who have a total bilirubin > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN;Serum albumin ≥ 3.0 g/dL;Serum creatinine < 2.0 x ULN.

Exclusion criteria

• Prostate cancer with neuroendocrine differentiation or small cell features
• Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
• History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer.
• Subjects who are planning bilateral orchidectomy during the treatment period of the study.
• Intolerable with darolutamide or ADT treatment.
• Candidates of other clinical trials.
• Any prior malignancy within 5 years.
• Complications include significant cardiovascular disease, active infection, astrointestinal disorders, or any other complications that in the opinion of the investigator.
• Any condition that in the opinion of the investigator would preclude participation in this study.