The aim of this study is to evaluate the efficacy and safety of apalutamide in combination with 89Sr as neoadjuvant therapy in prostate cancer with ≤10 bone metastases. The primary endpoint is PFS and the second endpoints are pCR, rPFS, PSA response, pain score, number and extent of bone metastases.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
240mg, po, qd
100\~150MBq(based on weight), iv, q90d
sc, 3.6mg, q30d or 10.8mg, q90d
zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGPFS
progression-free survival
Time frame: Up to 2 years after radical prostatectomy
pCR
pathological complete response
Time frame: Up to 1 year
rPFS
radiographic progression-free survival
Time frame: Up to 3 years
PSA response rate
more than 50% decrease from baseline
Time frame: Up to 3 years
pain score
Measurement of pain assessed by a Visual Analogue Scale (VAS). The analogous visual scale used for this study measures from 0 to 10 the intensity of pain with a series of "faces" that show the intensity in the pain experimentation with categories such as "No pain" in number 0, mild in number 1-3, moderate in number 4-6, intense in number 7-9 and worst in number 10.
Time frame: Measured at baseline and follow up visits throughout the study, an average of 3 years
number and extent of bone metastases
Bone Scan
Time frame: Up to 3 years
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