metastatic hormone-sensitive low-burden prostate cancer
Conditions
Interventions
treatment group:Robot-assisted laparoscopic prostatic carcinoma resection + enlarged lymph node dissection
control group:ADT + apatamine endocrine therapy
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
Male
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Men aged 40-75 years; 2. Subjects histologically or cytologically diagnosed with prostate adenocarcinoma without the histological features, such as neuroendocrine differentiation, signet ring cell or small cell carcinoma; 3. Subjects had metastatic prostate cancer that presented at initial treatment as either positive bone scan (bone disease) or metastatic (soft tissue) on CT/MRI scan or metastatic on PSMA scan and had a low tumor load (as defined by the CHAARTED study); 4. Subjects whose duration of previous surgical castration or drug castration (ADT) treatment was = 1.5 x 10^9 / L, platelet count >= 100 x 10^9 / L, and hemoglobin >= 9 g/dL; Renal function: serum creatinine <= 1.5×ULN; Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5×ULN, TBIL <= 1.5×ULN; Coagulation function: International standardized ratio (INR) < 1.5; 8. Subjects will be treated with apatamide regimen during hormone sensitivity therapy; 9. Subjects accept surgical treatment and voluntarily participates in the study. The subject must sign an informed consent form (ICF), indicating that he/she understands the purpose and procedures of the study and is willing to participate in the study. Subjects must be willing and abide by the prohibitions and restrictions specified in the study protocol.
Exclusion criteria
Exclusion criteria: 1. Subjects with neuroendocrine, small cell, or sarcomatoid features in prostate histopathology; 2. Subjects with more than 4 metastatic lesions and >= 1 axial metastasis, or visceral metastasis radiographically; 3. Subjects diagnosed with metastatic hormone-sensitive prostate cancer for more than 9 months or developing biochemical or radiographic progression; 4. Subjects with unresectable primary prostate cancer by imaging assessment before enrollment; 5. Subjects with the primary focus of prostate cancer treated with prefocal therapy, radiotherapy, palliative endoscopic resection and other local treatments; 6. Subjects with severe or uncontrolled co-infection; 7. Subjects with NYHA class III/IV congestive heart failure, unstable angina or a history of myocardial infarction within the past 6 months; 8. Subjects with uncontrolled severe hypertension, ongoing uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease or HIV infection; 9. Subjects with cured basal or squamous cell skin cancer who have had other malignancies in addition to prostate cancer in the past 5 years may be included; 10. Subjects with a mental illness, mental disability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to PSA progression (>= 2 ng/mL); | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiology progression-free survival (rPFS);Time to castration resistance;PSA remission (>= 50%);PSA remission (>=90%);Time of starting new antineoplastic therapy;Symptom remission; | — |
Countries
China
Contacts
Public ContactLiu Bianjiang
Outcome results
None listed