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

CellMax Life

Status: Unknown

Conditions: Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT03488706

CMx-CTC-PC-001

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Male

Ages: 20 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Gray Zone Group

Description:

The gray zone group PSA between 4.00 to 10.99 ng/ml.