Condition: Metastatic Prostate Cancer, Intermitent Anti-androgen Therapy

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT06177015

Sponsor: The First Affiliated Hospital with Nanjing Medical University

Phase: Phase 3

Eligibility:

• Age: minimum 40 Years maximum 80 Years
• Gender: Male

Inclusion Criteria:

1. Patients must meet all of the following criteria to be eligible for this study:
2. Male aged ≥18 years;
3. Histologically or cytologically confirmed prostate adenocarcinoma;
4. Metastatic disease (confirmed by conventional imaging);
5. ECOG performance status of 0-1;
6. Suitable for ADT and docetaxel treatment;
7. Good bone marrow, kidney, and liver function:
8. (1) Hematological examination (no blood transfusion or use of hematopoietic growth factors within 7 days before screening):
9. Hemoglobin (HB) ≥ 90g/L;
10. Absolute neutrophil count (ANC) ≥ 1.5×109/L;
11. Platelets (PLT) ≥ 80×109/L;
12. (2) Blood biochemistry examination (no blood transfusion or albumin within 7 days before screening):
13. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
14. Total bilirubin (TBIL) ≤ 2.0 × ULN;
15. Serum creatinine (Cr) ≤ 2.0×ULN;
16. Willing to participate in this study, sign an informed consent form, and have good compliance

Exclusion Criteria:

1. No metastatic disease;
2. Prior treatment with: a) Second-generation ARis or other experimental ARis b) CYP17 enzyme inhibitors such as abiraterone acetate or oral ketoconazole for anti-tumor treatment of prostate cancer c) Chemotherapy or immunotherapy prior to randomization for prostate cancer
3. Received radiotherapy within 2 weeks before starting 6 months of darolutamide + docetaxel + ADT treatment;
4. Stroke, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV);
5. History of malignant tumors;
6. Planned receipt of other anti-tumor treatment during the study treatment period;
7. Known allergy to the above drug components;
8. Difficulty swallowing, chronic diarrhea, intestinal obstruction, and various factors affecting drug intake and absorption;
9. Refusal to sign the informed consent form;
10. Investigator's opinion that the participant is not suitable for inclusion.

View trial on ClinicalTrials.gov