Efficacy and Safety of Apantamide Combined With Docetaxel and ADT vs. Apantamide Combined
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 gr
| Condition(s) | Cohort Studies |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. Age ≥ 18 years, male; 2. It was diagnosed as prostate adenocarcinoma by histological or cytological examination, and its pathological type was adenocarcinoma; 3. Bone imaging, CT or MRI showed ≥ 4 bone metastases (≥ 1 bone metastasis located outside the pelvis or spine) or visceral metastasis; 4. .Patients with recurrence after new or local treatment are sensitive to endocrine therapy; 5. Patients receiving ADT treatment (drug or surgical castration), with or without the first generation of antiandrogen drugs, for no more than 3 months, and without evidence of soft tissue imaging disease progression (according to RECIST 1.1 standard) or clinically significant PSA increase (after serum testosterone reaches the castration level, PSA increases by 50% from the lowest lev |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Lead sponsor | Qilu Hospital of Shandong University |
| Locations | Jinan, Shandong, China |
| Start date | 2023-03-01 |
| NCT ID | NCT05713578 |
| Official listing | https://clinicaltrials.gov/study/NCT05713578 |