Cancer of the Prostate Clinical Trial
Official title:
A Prospective, Randomized Blinded, Shared Decision Impact Trial of the ExoDx Prostate (IntelliScore), EPI Test, in Men Presenting for Initial Biopsy.
Verified date | May 2022 |
Source | Exosome Diagnostics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to investigate the utility of a validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy.
Status | Active, not recruiting |
Enrollment | 1000 |
Est. completion date | September 29, 2023 |
Est. primary completion date | September 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 50 Years and older |
Eligibility | 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. - Known hepatitis (all types) and/or HIV documented in patient's medical record. - Patients with history of concurrent renal/bladder tumors. |
Country | Name | City | State |
---|---|---|---|
United States | Chesapeake Urology Research Associates | Towson | Maryland |
Lead Sponsor | Collaborator |
---|---|
Exosome Diagnostics, Inc. | CareFirst BlueCross BlueShield, Chesapeake Urology Research Associates |
United States,
Tutrone R, Donovan MJ, Torkler P, Tadigotla V, McLain T, Noerholm M, Skog J, McKiernan J. Clinical utility of the exosome based ExoDx Prostate(IntelliScore) EPI test in men presenting for initial Biopsy with a PSA 2-10 ng/mL. Prostate Cancer Prostatic Dis — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate performance of the ExoDx Prostate(IntelliScore) | Evaluate performance of the ExoDx Prostate(IntelliScore) to reduce the number of initial prostate biopsies by greater than or equal to 15% for men with an elevated prostate specific antigen between 2-10ng/mL presenting for a biopsy in consultation with their urologist. | 6 Months |
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