This is a multicenter, prospective, cohort study to evaluate the efficacy and safety of apantamide+docetaxel+ADT versus apantamide+ADT in the treatment of patients with high tumor mHSPC.220 patients with high tumor mHSPC will be included and divided into two treatment groups according to the treatment plan:Treatment group 1: apantamide+docetaxel+ADT,Treatment group 2: apantamide+ADT treatment.The study continued treatment until the patient could not obtain clinical benefits or had intolerable toxic reactions or the patient withdrew the informed consent, whichever occurred first.
Age ≥ 18 years, male;
It was diagnosed as prostate adenocarcinoma by histological or cytological examination, and its pathological type was adenocarcinoma;
Bone imaging, CT or MRI showed ≥ 4 bone metastases (≥ 1 bone metastasis located outside the pelvis or spine) or visceral metastasis;
.Patients with recurrence after new or local treatment are sensitive to endocrine therapy;
Have a history of hypersensitivity or intolerance to any drug used in the study;
Plan to receive any other anti-tumor treatment during the study period;
Patients who have received the second generation of androgen receptor (AR) inhibitors in the past, such as apantamide, enzalutamide, darotamide (ODM-201) or other AR inhibitors, CYP17 enzyme inhibitors, such as abietron acetate or oral ketoconazole, chemotherapy or immunotherapy, as well as adjuvant or new adjuvant therapy, should also be excluded;
Four weeks before the start of the study, he received plant drugs (such as saw palmetto) that have the effect of anti prostate cancer or reducing PSA level;
Parallel
apantamide+docetaxel+ADT
DrugApantamide, 240 mg (4 × 60 mg tablets), once a day, orally; ADT regimen was treated with gonadotropin releasing hormone analog (GnRHa), including GnRHa agonist or GnRHa antagonist. The type, frequency and dose of ADT to be used in each research center are determined by the investigator; The treatment of docetaxel was started within 6 weeks after the treatment of apantamide and ADT. The single dose of docetaxel was 75 mg/m2, intravenous drip for 1 hour, repeated every 3 weeks, and docetaxel lasted for 6 cycles.
apantamide+ADT treatment
Drugapantamide+ADT treatment
3-year radiographic progression free survival (rPFS) rate
RPFS is defined as the time from the start of study treatment to the occurrence of imaging progress or death due to any reason, whichever occurs first.（%）
Time to CRPC
Time to CRPC（months）
To PSA progress time;
Time to PSA progress（months）
Asymptomatic skeletal event (SSE) survival;
Asymptomatic skeletal event (SSE) survival.（%）
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