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

NCT02771769 | Terminated

• 1 other identifier: CHX-2015-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostatic Neoplasms

Keywords

cell-free DNA; copy number instability; liquid biopsy; cancer

Outcome Measures

Primary Outcomes (1)

• CNI correlation with biopsy

  To determine if copy number instability (CNI scores) derived from analysis of cell-free cancer DNA (cfDNA) in patients undergoing prostate biopsy correlates with biopsy diagnosis of prostate cancer.

  Through completion of study and all data analysis which may take up to 2 years.

Secondary Outcomes (2)

• CNI correlation with BPH

  Through completion of study and all data analysis which may take up to 2 years.

• CNI correlation with PIN

  Through completion of study and all data analysis which may take up to 2 years.

Interventions

blood draw OTHER

Participants will have a venous blood draw of \~20mLs before prostate biopsy. The biopsy will then be performed and histologically graded for any malignancy present. This grade will be statistically analyzed with respect to the Copy Number Instability (CNI) determined from the results of the molecular examination of the cell-free DNA in the blood.

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male subjects between the ages of 21-80 who are scheduled for a prostate biopsy and meet one of the eligibility criteria listed below.

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

Sponsors & Collaborators

• Chronix Biomedical Corporation: lead
• Smerud Medical Research International AS: collaborator
• Vanderbilt University: collaborator

Study Sites (2)

University of Maryland Cancer Center

Baltimore, Maryland, 21201, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (3)

• Chou R, Croswell JM, Dana T, Bougatsos C, Blazina I, Fu R, Gleitsmann K, Koenig HC, Lam C, Maltz A, Rugge JB, Lin K. Screening for prostate cancer: a review of the evidence for the U.S. Preventive Services Task Force. Ann Intern Med. 2011 Dec 6;155(11):762-71. doi: 10.7326/0003-4819-155-11-201112060-00375. Epub 2011 Oct 7.

  PMID: 21984740 RESULT

• Bill-Axelson A, Holmberg L, Garmo H, Rider JR, Taari K, Busch C, Nordling S, Haggman M, Andersson SO, Spangberg A, Andren O, Palmgren J, Steineck G, Adami HO, Johansson JE. Radical prostatectomy or watchful waiting in early prostate cancer. N Engl J Med. 2014 Mar 6;370(10):932-42. doi: 10.1056/NEJMoa1311593.

  PMID: 24597866 RESULT

• Renard E, Bringer J, Augustin I, Orsetti A, Jaffiol C. [Value of dexamethasone suppression tests in the diagnosis of hypercortisolism of ectopic or adrenal origin]. Presse Med. 1989 Feb 25;18(8):435. No abstract available. French.

  PMID: 2540489 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Cell-free and cell-associated DNA will be obtained from plasma and peripheral blood mononuclear cells, respectively. DNA will be stored until study is completed and data are published.

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• David F Penson, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 13, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)