Analysis of Cell-free DNA (cfDNA) in Men With Elevated PSA Levels

Stopped early

Conditions studied: Prostatic Neoplasms

In brief

This is a multi-centre prospective study in which blood samples will be taken from 1500 male patients aged between 21-80 scheduled for prostate biopsy. Analysis of cell-free cancer DNA extracted from these samples will be undertaken to determine whether copy number instability scores derived from the cfDNA correlates with PSA screening levels and prostate biopsy results (i.e. Gleason score) in these patients.

Key facts

Study ID

NCT02771769

Run by

Chronix Biomedical Corporation

People needed

500

Starts

2016-01-01

Expected to finish

2020-01-01

Last updated by the study team

2020-01-18

Who can join

Age: 21 and older, up to 80. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Who, in the opinion of the site Investigator, have an abnormal PSA level as measured by a CLIA certified laboratory or non-USA equivalent within the last 60 days, and/or
• Who, in the opinion of the site Investigator, have an abnormal digital rectal examination

You may not qualify if…

• Male subjects with active or historical histologically confirmed diagnosis of malignancy
• Male subjects who have participated in a clinical trial involving an investigational drug within the 28 days prior to signing the informed consent form

Where it is running

• University of Maryland Cancer Center — Baltimore, Maryland, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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