prostate cancer
Conditions
Interventions
Experimental group:Rezvilutamide 240 mg orally once daily before or after breakfast,28 days per cycle for a total of 12 treatment cycles (6 cycles before and 6 cycles following radical prostatectomy)
Comparator group:utamide 240 mg orally once daily before or after breakfast,28 days per cycle for a total of 12 treatment cycles (6 cycles before and 6 cycles following radical prostatectomy) Gosereli
Sponsors
The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age of=18 years old; 2.Pathologically diagnosed as prostate adenocarcinoma; 3. ECT diagnosed as oligometastatic prostate adenocarcinoma(=5); 4. .Subjects who are candidates for and plan to undergo radical prostatectomy (removal of the entire prostate and seminal vesicle plus pelvic lymphadenectomy) 5.ECOG PS score of 0 or 1; 6.The patient is able to swallow oral medication smoothly; 7.The functional level of organs must meet the following requirements:ANC=1.5×10 9 /L;PLT=80×10 9 /L ; Hb = 100 g/L ; TBIL = 1.5×ULN ; ALT AST =2.0×ULN;BUNCr=1.5×ULN;K=3.5 mmol/L; 8.The subjects must be willing and able to comply with the prohibitions and restrictions stipulated in this agreement; 9.Voluntarily participate in this clinical trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1.Unsigned informed consent form; 2.Prostate small cell carcinoma or neuroendocrine tumor; 3.Subjects who received any prior treatment for prostate cancer,except medical ADT and/or first-generation androgen receptor antagonists (such as bicalutamide)for not more than 4 weeks; 4..Subjects who are planning bilateral orchidectomy during the treatment period of the study; 5.Subjects with dysphagia,chronic diarrhea,intestinal obstruction,or other factors affecting drug intake and absorption; 6.Subjects with a history of epilepsy,or diseases that can induce seizures occurred within 12 months prior to randomization (including a history of transient ischemic attack,stroke, traumatic brain injury,and cognitive impairment,requiring hospitalization); 7.The subject is known to be allergic or intolerant to revalutamide or its excipients; 8.Subjects who received any other investigational products or underwent major surgery within 4 weeks prior to randomization; 9.Patients who are unwilling to take effective contraceptive measures throughout the entire study treatment period and within 3 months after the last administration; 10.According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect the completion of this study, such as severe diabetes, thyroid disease, and mental illness or any other situation 11.Plan to receive any other anti-tumor treatment during this trial; 12.Uncontrolled high blood pressure(systolic blood pressure 160 mmHg or diastolic blood pressure 95 mmHg).If blood pressure can be effectively controlled by antihypertensive therapy,subjects with a history of hypertension are allowed to participate in the study; 13.Patients with active HBV or HCV infection (HBV virus copy number=104 copies/mL,HCV virus copy number =103 copies/mL),or active syphilis infection; 14.History of immunodeficiency (including HIV positive,other acquired,congenital immunodeficiency disease)or organ transplant history; 15.Imaging diagnosis of brain tumor lesions; 16.Study of other malignant tumors within 3 years prior to the first dose (in situ cancer with complete remission and excluding malignant tumors with slow progress); 17.Habitual constipation or diarrhea,irritable bowel syndrome,inflammatory bowel disease;abdominal fistula,gastrointestinal perforation or abdominal abscess.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 rate;pCR rate;MFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA response rate;time to CRPC;Radiographic Progression Free Survival(rPFS);time of occurrence of bone related events;OS;Adverse Event; | — |
Countries
China
Contacts
Public Contactzhiqiang zhang
The SecondAffiliated Hospital of Anhui Medical University
Outcome results
None listed