	US 12,292,443 B2
	Circulating tumor cell based biomarker composition for diagnosis and prognosis of metastatic prostate cancer
Jae Seung Chung, Busan (KR); Ki-Ho Han, Busan (KR); Hyung Seok Cho, Busan (KR); Jae Il Chung, Busan (KR); and Seok-Soo Byun, Seongnam-si (KR)
Assigned to INJE UNIVERSITY INDUSTRY-ACADEMIC COOPERATION FOUNDATION, Gimhae-si (KR); and SEOUL NATIONAL UNIVERSITY HOSPITAL, Seoul (KR)
Appl. No. 17/608,992
Filed by INJE UNIVERSITY INDUSTRY-ACADEMIC COOPERATION FOUNDATION, Gimhae-si (KR); and SEOUL NATIONAL UNIVERSITY HOSPITAL, Seoul (KR)
PCT Filed Apr. 28, 2021, PCT No. PCT/KR2021/005355 § 371(c)(1), (2) Date Nov. 5, 2021, PCT Pub. No. WO2021/221452, PCT Pub. Date Nov. 4, 2021.
Claims priority of application No. 10-2020-0052737 (KR), filed on Apr. 29, 2020.
Prior Publication US 2022/0214346 A1, Jul. 7, 2022
Int. Cl. G01N 33/574 (2006.01); A61K 31/337 (2006.01); A61P 35/00 (2006.01); C12Q 1/00 (2006.01); C12Q 1/68 (2018.01); C12Q 1/6886 (2018.01); G01N 33/00 (2006.01); G01N 33/50 (2006.01); G01N 33/543 (2006.01)

CPC G01N 33/57492 (2013.01) [G01N 33/57434 (2013.01); A61K 31/337 (2013.01); A61P 35/00 (2018.01); C12Q 1/6886 (2013.01); C12Q 2600/118 (2013.01); C12Q 2600/158 (2013.01); G01N 33/54326 (2013.01); G01N 2333/4742 (2013.01); G01N 2333/705 (2013.01); G01N 2333/70596 (2013.01); G01N 2333/723 (2013.01)]

3 Claims

1. A method of diagnosing and treating metastatic prostate cancer comprising:

(a) separating circulating tumor cells (CTCs) isolated from a biological sample at a flow rate of 2 ml/h using a disposable microfluidic device;

(b) extracting mRNA from the separated circulating tumor cells (CTCs);

(c) measuring mRNA level of genes comprising AR (Androgen receptor), AR-V7 (Androgen receptor variant 7), EpCAM (Epithelial cell adhesion molecule), KRT-19 (Cytokeratin 19), PSA (Prostate specific antigen) and PSMA (Prostate specific membrane antigen) by droplet digital PCR using the extracted mRNA as a template:

(d) classifying as metastatic castration-resistant prostate cancer (mCRPC) when the mRNA levels of all of the genes are increased compared to that of a healthy person; and

(e) administering a taxane therapy selected from the group consisting of docetaxel, cabazitaxel, and estramustine phosphate to a subject classified as having the mCRPC in step (d).