About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- apantamide+docetaxel+ADT
- apantamide+ADT treatment