The neoadjuvant therapy with apalutamide can significantly improve the prognosis of patients with high-risk and oligometastatic prostate cancer, lower the rate of positive margins, reduce recurrence, and show high safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
apalutamide as neoadjuvant therapy
zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGrPFS
radiographic progression-free survival
Time frame: Change from Baseline at preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
pCR
pathological complete response
Time frame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
PFS
positive margin rate; progression-free survival
Time frame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
PSA response rate:
more than 50% decrease from baseline
Time frame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
TTPP
time to PSA progression
Time frame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
time to BCR after surgery
Time frame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
pathological stage
Time frame: preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
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