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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03488706

Enrollment

500

Registered

2018-04-05

Start date

2018-01-17

Completion date

2021-06-02

Last updated

2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

20 Years to 99 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Taiwan

Contacts

Primary ContactJoy Chang

joy@cellmaxlife.com+886-2-26558455

Outcome results