Prostate cancer
Conditions
Interventions
Test group:docetaxel combined with abiraterone nanocrystals as neoadjuvant therapy
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 18-75 years old, planning to undergo radical prostatectomy; 2. ECOG score =1.5×10^9/L; •PLT >=100×10^9/L; •Hb >=90 g/L; TBIL =50%; •QTcF <=450 ms. 6. Subjects whose partners are fertile women should undergo surgical sterilization or agree to use effective contraception methods during the trial period and within 3 months after the last administration of the study drug; 7. The subjects voluntarily joined this study, signed a written informed consent form, and are expected to have good compliance with the research protocol.
Exclusion criteria
Exclusion criteria: 1. Previously received abiraterone, any second-generation endocrine therapy (including but not limited to rivaromide, darotamine, apatamide, enzalutamide, etc.), or radiochemotherapy; 2. Pathology contains non adenocarcinoma components, such as neuroendocrine differentiation or small cell features; 3. At the time of enrollment, serum PSA was detected to be less than 0.2ng/ml; 4. Prostate cancer patients with bone or visceral metastases (any M1); 5. Received other clinical trial drug treatments and major surgeries within 4 weeks before enrollment; 6. There are factors such as inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that affect medication intake and absorption; 7. Have a history of epilepsy or have experienced diseases that can trigger epileptic seizures within the 12 months prior to randomization (including a history of transient ischemic attacks, stroke, traumatic brain injury with consciousness disorders requiring hospitalization); 8. Active heart disease within the first 6 months of randomization, including severe/unstable angina, myocardial infarction, symptomatic congestive heart failure (heart function class III or IV), and drug-induced ventricular arrhythmias; 9. Individuals with active HBV and HCV infection (HBsAg positive and virus copy number >= 500 IU/mL, HCV antibody positive and HCV RNA above the detection limit of the analytical method); 10. Individuals with a known history of allergies to abiraterone and LHRHa drugs and their components; 11. Individuals with a history of congenital immunodeficiency or organ transplantation, or HIV positive subjects who meet one or more of the following criteria: Not receiving highly effective antiretroviral therapy; Change antiretroviral therapy within 6 months prior to the start of screening; • Undertaking antiretroviral therapy that may interfere with the investigational drug (please consult the sponsor before enrollment); CD4 count<350/mm3 during screening; Opportunistic infections that meet the definition of acquired immunodeficiency syndrome occurred within 12 months prior to the start of screening. 12. Within the past 3 years prior to enrollment, the patient had other malignant tumors (excluding in situ cancer that has completely resolved and malignant tumors that have been determined by researchers to have slow progression); 13. The researchers determined that participants with ejaculation ability and sexual activity were unwilling to use the contraceptive measures specified in the protocol throughout the entire study treatment period and within 3 months after the last dose;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimum residual lesions; | — |
Secondary
| Measure | Time frame |
|---|---|
| pathologic complete response;Pathological Downstaging Rate;Lymph node positivity rate;Positive Surgical Margin Rate;PSA Response Rate;safety; | — |
Countries
China
Contacts
Public ContactJinchao Chen
Zhejiang Cancer Hospital
Outcome results
None listed