ExoDx Prostate Evaluation in Prior Negative Prostate Biopsy Setting

  • STATUS
    Recruiting
  • End date
    Jul 5, 2021
  • participants needed
    350
  • sponsor
    Exosome Diagnostics, Inc.
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Updated on 5 January 2021
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Investigator
Sonia Kumar, PhD
Primary Contact
Chesapeake Urology Research Associates (7.6 mi away) Contact
+1 other location
prostate specific antigen
biopsy of prostate

Summary

The study is designed to confirm the performance of the ExoDx Prostate test in prior negative biopsy patients now presenting for a repeat prostate biopsy.

Note: ExoDx Prostate test results are collected for correlation to biopsy results and are not disclosed to the physician or study subject.

Description

Primary Endpoint:

Evaluate the correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort.

Secondary Endpoints (exploratory):

  1. Evaluate the clinical performance of the ExoDx Prostate test at the cut-point of 15.6 defined for the initial biopsy patient cohort.
  2. Associate ExoDx Prostate test results with other ancillary studies including the use of radiographic imaging (e.g. multiparametric MRI).
  3. Evaluate the correlation of ExoDx Prostate as a function of risk. It is known that a higher ExoDx Prostate score correlates to a higher risk of finding prostate cancer, including HGPC, upon biopsy.
  4. Evaluate ExoDx Prostate with and without inclusion of standard of care parameters such as PSA, ethnicity, DRE, age and family history.

Details
Treatment ExoDx Prostate
Clinical Study IdentifierNCT04357717
SponsorExosome Diagnostics, Inc.
Last Modified on5 January 2021

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Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 50 yrs?
Are you male?
Do you have any of these conditions: Prostate Cancer or Prostate Disorders or Prostatic disorder or Prostate Cancer, Early, Recurrent or Malignant neoplasm of prostate?
Do you have any of these conditions: Malignant neoplasm of prostate or prostate cancers or Prostatic disorder or Prostate Disorders or Prostate Cancer or prostate carcinoma or Prostate Ca...?
Do you have any of these conditions: prostate cancers or Prostatic disorder or Prostate Disorders or prostate carcinoma or Prostate Cancer or Prostate Cancer, Early, Recurrent or Malignan...?
+ years of age
Clinical suspicion for prostate cancer
Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
At least one (1) prior negative prostate biopsy

Exclusion Criteria

Use of medications or hormones that are known to affect serum PSA levels within 3-6 months of study enrollment including 5-alpha-reductase inhibitors used in the treatment of an enlarged prostate gland (benign prostatic hyperplasia). Drugs in this class are finasteride (Proscar, Propecia) and dutasteride (Avodart)
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 (BPH) or lower urinary track symptoms within 6 months of study enrollment
No known hepatitis status (all types) and/or HIV documented in patient's medical record
Patients with history of concurrent renal/bladder tumors
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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