Assessing Circulating Tumor Cell as a Biomarker for Prostate Cancer Detection in Patients With Gray Zone PSA Level
- Conditions
- Prostate Cancer
- Registration Number
- NCT03488706
- Lead Sponsor
- CellMaxLife
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 500
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Circulating tumor cells detection Prior to prostate biopsy Using a circulating-tumor-cell (CTC) test to detect prostate cancer in patients in the PSA "gray zone" level
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Linkou Chang Gung Memorial Hospital
🇨🇳Taoyuan City, Taiwan