This randomized, controlled, multi-center clinical trial aims to evaluate the efficacy and safety of prostatectomy for castration-Naive oligometastatic prostate cancer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection will be performed.
1000mg(4 tablets, 250mg per tablet) daily for 6 cycles
5 mg oral low dose prednisone taken along with Abiraterone Acetate Tablets
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Time to PSA progression progression
PSA progression is defined as elevated PSA levels(≥2ng/ml) for no less than 2 measurements at least 1 week apart.
Time frame: up to 2 years
Time to Radiographic progression
Radiographic progression is defined as newly discovered soft tissue metastasis according to the RECIST 1.1 or at least 2 bone lesions.
Time frame: up to 2 years
rPFS (radiographic progression free survival)
The time of radiographic progression free survival
Time frame: up to 2 years
Time to castration resistance
The time to castration resistance
Time frame: up to 2 years
Time to PSA remission (≥50%) and time to PSA remission (≥90%)
Time to the point when PSA drop to below 50% initial PSA level. Time to the point when PSA drop to below 10% initial PSA level.
Time frame: up to 2 years
Time to new anti-cancer treatment
Time to the point when onther anti-cancer treatment is necessary
Time frame: up to 2 years
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Hypodermic injection of Luteinizing Hormone-Releasing Hormone Analog every 4 weeks including goserelin, leuprolide, triptorelin ect.