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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Darolutamide: oral administration, 600 mg per dose, twice daily, taken with food.
Docetaxel: 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: 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)
Time frame: Every 3 months (±14 days) up to 36 months after surgery
Pathological Downstaging Rate after Radical Prostatectomy
Time frame: On Surgery day
Incidence of Treatment-Related Adverse Events
Time frame: From screening visit to 30 days after the last neoadjuvant dose or start of new anticancer therapy
Time to Castration-Resistant Prostate Cancer (CRPC) at 3 Years
Time frame: every 3 months PSA tests and every 6 months imaging assessments up to 36 months after surgery
Objective Response Rate (ORR)
Time frame: 2-4 weeks after completion of neoadjuvant therapy
3-year Radiographic Progression-Free Survival (rPFS)
Time frame: Every 6 months (±1 month) post-surgery until 36 months post-surgery (months 6, 12, 18, 24, 30, 36)
Undetectable PSA Rate post-Radical Prostatectomy
Time frame: 6 weeks post-surgery (±7 days)
Subject Quality of Life as assessed by FACT-P( Functional Assessment of Cancer Therapy - Prostate) scale
The FACT-P(Functional Assessment of Cancer Therapy - Prostate) scale will be used to assess the quality of life of subjects. The total score is calculated from the general functional and prostate cancer-specific subscale scores, with a total score range of 0 to 156, where higher scores indicate better functional status. Changes in the total score and individual domain scores will be analyzed.
Time frame: Baseline (V0), post-neoadjuvant/pre-surgery (V5), and at 6, 12, 24, 36 months post-surgery (±14 days)
Perioperative Complications
Time frame: From surgery date through 90 days post-surgery
Positive Surgical Margin Rate after Radical Prostatectomy
Time frame: On surgery day
3-year biochemical progression-free survival (bPFS)
Time frame: Every 3 months (±14 days) up to 36 months after surgery
Time to Castration-Resistant Prostate Cancer (CRPC) at 3 Years
Time frame: PSA tests every 3 months and imaging assessments every 6 months up to 36 months post-surgery
Pathological Complete Response (pCR) or Minimal Residual Disease (MRD) Rate
Time frame: On surgery day
3-year Overall Survival (OS)
Time frame: Every 3 months (+/-1 month) post-surgery until 36 months post-surgery
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