The goal of this study is to evaluate the efficacy and safety of darolutamide combined with docetaxel and ADT compared to docetaxel combined with ADT in treating locally advanced prostate cancer patients scheduled for radical prostatectomy. The participant population includes adult males with locally advanced prostate cancer (cT3b-cT4, N0, M0 or any cT, N1, M0). The main questions it aims to answer are:
Does the combination of darolutamide, docetaxel, and ADT improve treatment outcomes compared to docetaxel combined with ADT? What are the safety profiles and adverse effects associated with each treatment group? Researchers will compare the control group (docetaxel combined with ADT) to the experimental group (darolutamide combined with docetaxel and ADT) to see if the experimental treatment is more effective.
Participants will:
Receive either docetaxel combined with ADT or darolutamide combined with docetaxel and ADT for 4 cycles (16 weeks) as neoadjuvant treatment.
Undergo radical prostatectomy after completing the neoadjuvant treatment. Be followed up for 36 months post-surgery to assess treatment efficacy and safety.
Male, age >= 18 years and <= 75 years at the time of signing the informed consent form;
Confirmed as prostate cancer by histological or cytological examination, and planned for radical prostatectomy;
Clinical stage conforms to the definition of locally advanced prostate cancer: cT3b-cT4, N0, M0 or any cT, N1, M0 (based on PSMA-PET/CT examination);
Eastern Cooperative Oncology Group (ECOG) performance status score is 0-1;
Pathological diagnosis of neuroendocrine prostate cancer, including small cell carcinoma;
Prior local or systemic treatment for prostate cancer, including but not limited to radiotherapy, chemotherapy, or endocrine therapy;
Confirmed bone metastasis, hepatic metastasis, brain metastasis, or other visceral metastases on imaging;
Known hypersensitivity to the study drugs (active ingredients or excipients) or drugs of the same class;
Parallel
Darolutamide
DrugDarolutamide: oral administration, 600 mg per dose, twice daily, taken with food.
docetaxel
DrugDocetaxel: intravenous injection, 75 mg/m², once every 3 weeks, for a total of 4 doses/cycles. (Oral prednisone acetate should be started 14 days before docetaxel chemotherapy at 5 mg twice daily and discontinued 3 weeks after the last chemotherapy cycle.)
ADT
DrugADT: leuprorelin, goserelin, or triptorelin, selected by the investigator according to the patient's condition, administered by subcutaneous or intramuscular injection, using a once-monthly formulation uniformly.
3-year biochemical progression-free survival (bPFS)
Pathological Downstaging Rate after Radical Prostatectomy
Incidence of Treatment-Related Adverse Events
Time to Castration-Resistant Prostate Cancer (CRPC) at 3 Years
Objective Response Rate (ORR)
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RenJi Hospital
Lead sponsor
Bayer
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
