Status:
RECRUITING
Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Metastatic Prostate Cancer
Intermitent Anti-androgen Therapy
Eligibility:
MALE
40-80 years
Phase:
PHASE3
Brief 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.
Detailed Description
Patients will firstly receive 6 months of darolutamide in combination with docetaxel and ADT treatment. 1\. When the patient reaches: 1. PSA ≤ 0.2ng/ml 2. Or PSA \> 0.2ng/ml but with more that 90% d...
Eligibility Criteria
Inclusion
- Patients must meet all of the following criteria to be eligible for this study:
- Male aged ≥18 years;
- Histologically or cytologically confirmed prostate adenocarcinoma;
- Metastatic disease (confirmed by conventional imaging);
- ECOG performance status of 0-1;
- Suitable for ADT and docetaxel treatment;
- 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):
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
- Total bilirubin (TBIL) ≤ 2.0 × ULN;
- Serum creatinine (Cr) ≤ 2.0×ULN;
- 7\. Willing to participate in this study, sign an informed consent form, and have good compliance
Exclusion
- No metastatic disease;
- 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
- Received radiotherapy within 2 weeks before starting 6 months of darolutamide + docetaxel + ADT treatment;
- Stroke, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass surgery, congestive heart failure (New York Heart Association class III or IV);
- History of malignant tumors;
- Planned receipt of other anti-tumor treatment during the study treatment period;
- Known allergy to the above drug components;
- Difficulty swallowing, chronic diarrhea, intestinal obstruction, and various factors affecting drug intake and absorption;
- Refusal to sign the informed consent form;
- Investigator's opinion that the participant is not suitable for inclusion.
Key Trial Info
Start Date :
December 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06177015
Start Date
December 11 2023
End Date
December 31 2027
Last Update
December 26 2023
Active Locations (1)
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1
Urology dpt, First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029