Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC
Recruiting · NCT06177015 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Darolutamide continuousDarolutamide intermittent
What this trial is about
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.
Who can take part
Age range
40 Years to 80 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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) Hematological examination (no blood transfusion or use of hematopoietic growth factors within 7 days before screening):
- \. 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;
- \. Willing to participate in this study, sign an informed consent form, and have good compliance
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Urology dpt, First Affiliated Hospital of Nanjing Medical University - Nanjing, Jiangsu, China