Assessing Circulating Tumor Cell as a Biomarker for Prostate Cancer Detection in Patients With Gray Zone PSA Level

Prostate Cancer Clinical Trial

Official title:

Assessing Circulating Tumor Cell as a Biomarker for Prostate Cancer Detection in Patients With Gray Zone PSA Level

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03488706
• Other study ID #: CMx-CTC-PC-001
• Status: Recruiting
• First received: March 29, 2018
• Last updated: March 29, 2018
• Start date: January 17, 2018
• Est. completion date: June 2, 2021

Study information

• Verified date: March 2018
• Source: CellMaxLife
• Contact: Joy Chang
• Phone: +886-2-26558455
• Email: joy[@]cellmaxlife.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prostate cancer screening with PSA is plagued by high rate of unnecessary prostate biopsies, especially in the "gray zone" (4.00ng/ml e 10.99ng/ml). We introduce a new circulating-tumor-cell (CTC) biomarker for detection of prostate cancer in patients in the PSA "gray zone" level, with the clinically verified potential to substantially decrease the number of unnecessary prostate biopsies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2, 2021
• Est. primary completion date: December 12, 2018
• Gender: Male
• Age group: 20 Years to 99 Years

Eligibility

Inclusion Criteria:

• Subjects are willing to sign the informed consent and agree to comply with the study procedures.

• Age from 20 to 99 years old

• Subjects with a PSA 4.00- 10.99 ng/ml and will receive biopsy within 3 months

Exclusion Criteria:

• Age < 20 years

• Refuse to sign the informed consent form

• Received regional anesthesia and general anesthesia within one month

• Previous cancer history

• Autoimmune diseases

• Chronic inflammatory diseases

• Diagnosed with colorectal polyps or adenomas

• Acute inflammatory or infectious diseases in three months

• Other diseases decided by PI

Related Conditions & MeSH terms

• Neoplastic Cells, Circulating
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Taiwan	Linkou Chang Gung Memorial Hospital	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
CellMaxLife

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating tumor cells detection	Using a circulating-tumor-cell (CTC) test to detect prostate cancer in patients in the PSA "gray zone" level	Prior to prostate biopsy