Clinical Evaluation of the 'ExoDx Prostate IntelliScore' in Men Presenting for Initial Biopsy; Additional Confirmation Study Including Impact on Decision-making and Health Economics

Disease (cancer type)

Prostate Cancer

Contact information

  • Florida West Coast-Fort Myers: Lauren Embry (239) 344-2232
  • Florida East Coast: Peggy Mouradian (954) 370-7555
  • Florida West Coast-Naples: Brittney Decker (239) 434-6300

Patient Selection Criteria

Ages Eligible for Study: 50 Years and older (Adult, Senior) Sexes Eligible for Study: Male Gender Based Eligibility: Yes Gender Eligibility Description: Must be male to screen for prostate cancer Accepts Healthy Volunteers: Yes Sampling Method: Probability Sample Study Population Male, 50+ years of age with a clinical suspicion for prostate cancer based in part on an elevated Prostate-specific antigen (limit range: 2.0 - 10 ng/ mL), and or suspicious DRE, without the clinical history of a prior negative biopsy. Criteria Inclusion Criteria: 50 years of age Clinical suspicion for prostate cancer Elevated Prostate-specific antigen between: 2.0 - 10 ng/ mL No clinical history of a prior negative biopsy Exclusion Criteria: History of prior prostate biopsy. Use of medications or hormones that are known to affect serum Prostate-specific antigen levels within 3-6 months of study enrollment. Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment. History of prostate cancer. History of invasive treatments for benign prostatic hypertrophy (Benign Prostatic Hyperplasia) or lower urinary track symptoms within 6 months of study enrollment. No known hepatitis (all types) and/or HIV documented in patient's medical record. Patients with history of concurrent renal/bladder tumors.

Research sponsor

Exosome Diagnostics, Inc

Reference ID#

Exosome ECT2016-001A

State(s)

  • Florida
  • Michigan
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