Prostate Cancer
Conditions
Interventions
Intervention group :long course neoadjuvant novel hormonal therapy followed by radical prostatectomy
Control group:short course neoadjuvant novel hormonal therapy followed by radical prostatectomy
Sponsors
Lishui Central Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. age =18 years and =85 years, male; 2. Pathologically confirmed diagnosis of adenocarcinoma of the prostate without histological features of neuroendocrinization, imprinted cell or small cell carcinoma; 3. subjects with metastatic prostate cancer, as evidenced by a positive skeletal ECT result or metastatic lesions detected on CT/MRI scan at the time of initial treatment, with =5 skeletal or lymph node metastases and no visceral metastases; 4. Gleason score of = 9; 5. patients who, in the judgment of the investigator, are suitable for radical surgery after neoadjuvant therapy; 6. ECOG 0 or 1; 7. the patient is able to swallow oral medications without difficulty; 8. the functional level of the organs must meet the following requirements: ANC = 1.5 x 10^9/L; PLT = 100 x 10^9/L; Hb = 9 g/dL; TBIL = 1.5 x ULN; ALT and AST = 2.5 x ULN; BUN and Cr = 1.5 x ULN; and blood potassium = 3.5 mmol/L; 9. Subjects must be willing and able to comply with the prohibitions and restrictions set forth in this protocol; 10. voluntarily participate in this clinical trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. failure to sign informed consent; 2. small cell carcinoma or neuroendocrine tumor of the prostate; 3. prior treatment for prostate cancer of any kind, except pharmacological depot for no more than 4 weeks ± one generation of androgen receptor antagonists; 4. bilateral orchiectomy during the planned study period 5. the presence of inability to swallow, chronic diarrhea and intestinal obstruction, or other factors that interfere with drug administration and absorption 6. a history of epilepsy or a seizure-inducing illness (including a history of transient ischemic attack, stroke, or traumatic brain injury with impaired consciousness requiring hospitalization) occurring within 12 months prior to randomization; 7. the subject has a known allergy or intolerance to Revirudin or its excipients; 8. participation as a subject in a clinical trial of another drug where the last trial drug administration was within 4 weeks of the first administration of the study drug 9. patients who are unwilling to use effective contraception throughout the study treatment period and for 3 months after the final dose; 10. a concomitant medical condition (e.g., severe diabetes mellitus, thyroid disease, psychiatric illness, etc.) or any other condition that, in the judgment of the investigator, seriously jeopardizes the patient's safety, or interferes with the patient's ability to complete this study 11. receipt of any other anti-tumor therapy during the planned period of this trial; 12. uncontrolled hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 95 mmHg). Subjects with a history of hypertension will be allowed to participate in this study if their blood pressure can be effectively controlled with antihypertensive therapy; 13. Subjects with active HBV or HCV infection (HBV viral copy number ?104 copies/mL, HCV viral copy number ?103 copies/mL), or active syphilis infection; 14. History of immunodeficiency diseases (including HIV test positive, other acquired, congenital immunodeficiency diseases) or history of organ transplantation; 15. patients with the presence of intracerebral tumor foci on imaging studies 16. other malignancies within 3 years prior to randomization (except carcinoma in situ in complete remission and malignancies with slow progression as determined by the investigator); 17. habitual constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease; abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to the first dose of the drug; the presence of abnormalities of gastrointestinal function, which, in the judgment of the investigator, may interfere with the absorption of the drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with grades 2-4 in the hormonal therapy response grading system for prostate cancer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Nadir PSA level;Overall survival;PSA response rate;Time to PSA progress;Radiographic Progression-Free Survival ;Proportion of R0 resection;Time to the bone-related event;Time to CRPC;Safety;Quality of life; | — |
Countries
China
Contacts
Public ContactTing Chen
Lishui Central Hospital
Outcome results
None listed