This trial is active, not recruiting.

Condition prostate cancer
Sponsor University of Arkansas
Start date January 2012
End date February 2019
Trial size 75 participants
Trial identifier NCT01514669, 133719


The purpose of this research study is to compare profiles in the blood and tears of patients with and without prostate cancer with the goal of developing a method of separating men with aggressive and non-aggressive disease.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional

Primary Outcomes

Tear Sample
time frame: 1 day

Eligibility Criteria

Male participants from 35 years up to 80 years old.

Inclusion Criteria: 1. Male, 35-80 years old 2. Patients who present for a routine check-up 3. Patients who present for the evaluation of an abnormal exam or test (elevated PSA, abnormal DRE, etc.) 4. Patients who present for the evaluation of a palpable nodule or induration on prostate exam 5. Patients may present with a biopsy proven prostate cancer from outside physician for inclusion into arms 2 or 3 6. For group 1 a negative prostate biopsy Exclusion Criteria: 1. Patient < 35 or > 81 years of age 2. Concurrent eye infection or trauma 3. Active conjunctivitis 4. Abnormal production of tears (too much or too little) 5. Any other conditions the PI or staff feels will not fulfill the criteria for study entry or will place the subject in a harmful environment 6. Atypia on prostate biopsy report

Additional Information

Official title Analyzing the Composition of Tears and Blood for Discovery of Novel Signatures of Aggressive Prostate Cancer
Principal investigator Alan Diekman, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by University of Arkansas.