DRUG
Darolutamide
Darolutamide: oral administration, 600 mg per dose, twice daily, taken with food.
Status
Not yet recruiting
Phase
Phase 2
Enrollment
200
Locations
0
Results
Not posted
Publications
0
Study summary
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.
Interventions
DRUG
Darolutamide: oral administration, 600 mg per dose, twice daily, taken with food.
DRUG
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.)
DRUG
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.
Timeline
First posted
Jul 28, 2026
Study start
Aug 1, 2026
Primary completion
Dec 31, 2031
Study completion
Dec 31, 2031
Results posted
Not reported
Registry updated
Jul 28, 2026
Outcomes
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
Time frame · Baseline (V0), post-neoadjuvant/pre-surgery (V5), and at 6, 12, 24, 36 months post-surgery (±14 days)
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.
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
Eligibility
Inclusion Criteria: 1. Male, age \>= 18 years and \<= 75 years at the time of signing the informed consent form; 2. Confirmed as prostate cancer by histological or cytological examination, and planned for radical prostatectomy; 3. 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); 4. Eastern Cooperative Oncology Group (ECOG) performance status score is 0-1; 5. Expected lifespan \>= 10 years; 6. Important laboratory indicators meet the following requirements: a. Hemoglobin \>= 90 g/L b. Serum total bilirubin \<= 1.5 times the upper limit of normal value, transaminase (AST/ALT) \<= 2.5 times the upper limit of normal value c. Serum albumin \>= 30 g/L d. Serum creatinine \<= 1.5 times the upper limit of normal value e. Absolute neutrophil count \>= 1.5 x 10\^9/L, platelet count \>= 100 x 10\^9/L; 7. No difficulty in swallowing (can take the medicine in whole), chronic diarrhea, intestinal obstruction or other factors affecting drug administration and absorption; 8. No use of opioid analgesics (including codeine, oxycodone, etc.) to relieve cancer pain; 9. If the spouse is a fertile female, the subject consents to take effective contraceptive measures during the treatment period and for 4 months after the surgery; 10. The subject voluntarily participates in this trial, signs the informed consent form, and is willing to comply with the requirements of the research protocol throughout the study period. Exclusion Criteria: 1. Pathological diagnosis of neuroendocrine prostate cancer, including small cell carcinoma; 2. Prior local or systemic treatment for prostate cancer, including but not limited to radiotherapy, chemotherapy, or endocrine therapy; 3. Confirmed bone metastasis, hepatic metastasis, brain metastasis, or other visceral metastases on imaging; 4. Known hypersensitivity to the study drugs (active ingredients or excipients) or drugs of the same class; 5. Contraindications to prednisone acetate or docetaxel, such as active infection, allergy, or other conditions; 6. Chronic disease requiring prednisone acetate at doses exceeding those specified in the protocol (5 mg orally twice daily, starting 14 days before docetaxel chemotherapy and stopping 3 weeks after the last chemotherapy cycle); 7. Poorly controlled hypertension despite medication (systolic blood pressure \>=160 mmHg or diastolic blood pressure \>=95 mmHg); 8. Active or symptomatic viral hepatitis or other chronic liver disease; known human immunodeficiency virus (HIV) infection; 9. History of pituitary or adrenal dysfunction; 10. Active autoimmune disease requiring hormonal therapy; 11. Major cardiovascular or cerebrovascular disease within 6 months prior to the start of study treatment, including: severe/unstable angina, myocardial infarction, congestive heart failure \[New York Heart Association (NYHA) class III or above\], cerebrovascular accident, or arrhythmia requiring pharmacological treatment; 12. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 13. Grade ≥2 peripheral sensory or motor neuropathy; 14. Other malignancies occurring within the past 2 years or currently concurrent malignancies; 15. Major surgery requiring general anesthesia within 28 days before the first dose; 16. Treatment with strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ketoconazole) or strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, phenobarbital, St. John's wort) that cannot be discontinued, and have not been stopped for at least 7 days before randomization; 17. History of epilepsy; 18. Alcohol or drug abuse or dependence; 19. Participation in another therapeutic clinical study within 1 month before the start of study treatment; 20. Any other condition that the investigator considers unsuitable for participation in this study;
Study locations
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
No PMID-linked publications were present in this registry snapshot.
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