Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

• Status: Recruiting
• Trial end date: 2027-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

To evaluate the efficacy and safety of intermittent use of darolutamide compared to long-term use in combination with ADT and docetaxel in the treatment of mHSPC patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Criteria

Inclusion Criteria:

Patients must meet all of the following criteria to be eligible for this study:

1. Male aged ≥18 years;

2. Histologically or cytologically confirmed prostate adenocarcinoma;

3. Metastatic disease (confirmed by conventional imaging);

4. ECOG performance status of 0-1;

5. Suitable for ADT and docetaxel treatment;

6. Good bone marrow, kidney, and liver function:

1. (1) Hematological examination (no blood transfusion or use of hematopoietic growth factors within 7 days before screening):

1. Hemoglobin (HB) ≥ 90g/L; 2. Absolute neutrophil count (ANC) ≥ 1.5×109/L; 3. Platelets (PLT) ≥ 80×109/L; 2. (2) Blood biochemistry examination (no blood transfusion or albumin within 7 days before screening):

1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN

2. Total bilirubin (TBIL) ≤ 2.0 × ULN;

3. Serum creatinine (Cr) ≤ 2.0×ULN;

7. 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.