Intermitent Anti-androgen Therapy, Metastatic Prostate Cancer
Conditions
Keywords
triple treatment regimen, mHPSC, Darolutemide
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% decrease comparing baseline 3. Without newly discovered metastatic lesions. They will be randomly assigned in a 1:1 ratio to either continuous treatment group or intermittent treatment group (1) Continuous treatment group: Darolutamide: 600mg, bid+ADT: Leuprorelin (3.6mg qm or 10.8mg q3m) or goserelin 80mg qm until mCRPC; (2) Intermittent treatment group: Only ADT as background treatment without Darolutamide. PSA check every three months, when the patient's PSA \> 1ng/ml (or PSA \> 1ng/ml and PSA has risen by more than 20% comparing baseline), restart the darolutamide, until mCRPC. 2\. When the patient: 1. PSA \> 0.2ng/ml and has not decreased by 90% compared to baseline 2. Or has new metastatic lesions, they will exit the study. Imaging assessment will be conducted every 3 months
Interventions
DRUGDarolutamide continuous
standard of care
DRUGDarolutamide intermittent
experimental group
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two independent arms
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Progression Free Survival | 36 months | rPFS |
| Overall Survival | 36 months | OS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to castration-resistant prostate cancer | 36 months | Time to mCRPC |
| Time to pain progression | through study completion, an average of 3 year | TTPP |
Countries
China
Contacts
Primary ContactShangqian Wang
Outcome results
None listed