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Clinical Validation of a Urinary Exosome Gene Signature in Men Presenting for Suspicion of Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02702856
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Exosome Diagnostics, Inc.

Brief Summary:
Validate a non-DRE exosome gene expression test, with an NPV >/= 90% certainty, will exclude the presence of high gleason grade/ score (>/=7) prostate cancer in a prostate needle biopsy.

Condition or disease Intervention/treatment
Prostate Cancer Other: ExoIntelliScore Prostate

Detailed Description:
The purpose of this multi-center clinical study is to determine the association of an Exosome Urine Test score with the presence of high Gleason grade / score (GS>/=7) prostate cancer on a prostate needle biopsy and validate the assay's performance characteristics in men presenting to their urologist with or without a previous negative biopsy, and recommended for an initial or subsequent biopsy. The results of this study are to support the use of this assay as a laboratory developed test. A secondary objective is to develop an assay that accurately predicts the presence of any Gleason grade prostate cancer in men at risk for prostate cancer.

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Study Type : Observational
Actual Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Validation of a Urinary Exosome Gene Signature in Men Presenting for Suspicion of Prostate Cancer
Study Start Date : May 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Men screened for prostate cancer Other: ExoIntelliScore Prostate



Primary Outcome Measures :
  1. Correlate an exosome gene expression signature with the presence or absence of high grade prostate cancer in the prostate needle biopsy. [ Time Frame: one year ]
    Validate various thresholds utilizing the exosome RNA gene signature to stratify patients based on the likelihood of having any Gleason pattern 4 disease present within the biopsy (or when available the prostatectomy specimen surgical pathology report) for first time biopsy patients in the PSA gray zone of 2.0-10 ng/mL. In our earlier cohort analyses and in the literature there is an expected 20-25% of patients who will present with Gleason score >/=7 and the prevalence of a dominant Gleason 4 varies considerably dependent upon studies from 17-30%.


Biospecimen Retention:   Samples Without DNA
Prospectively collect approximately 25-40mL of random, non-DRE, non catheter urine, in a standard, reduced size, clinical capture vessel.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Community Sample
Criteria

Inclusion Criteria:

  1. Male, >50 years of age with a clinical suspicion for prostate cancer based in part on an elevated PSA (limit range: 2.0 - 20 ng/ mL), and or suspicious DRE, with or without the clinical history of a single prior negative biopsy, and who have been recommended for a repeat and or first time biopsy.
  2. The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents.

Exclusion Criteria:

  1. Use of medications or hormones that are known to affect serum PSA levels within 3-6 months of study enrollment.
  2. Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
  3. History of prostate cancer.
  4. History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary track symptoms within 6 months of study enrollment.
  5. Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion or results of this trial, or constitutes an unacceptable risk to the subject.
  6. Participation in pharmaceutical or treatment related clinical study within 6 months of study enrollment. Exception: Trials for non-prostate conditions may be acceptable, with approval by the investigator and Sponsor.
  7. No known hepatitis (all types) and/or HIV documented in patient's medical record.
  8. Patients with history of concurrent renal/bladder tumors within 6 months of study enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02702856


Sponsors and Collaborators
Exosome Diagnostics, Inc.
Investigators
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Study Director: Roger Tun Exosome Diagnostics, Inc.

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Responsible Party: Exosome Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT02702856     History of Changes
Other Study ID Numbers: ECT2014-001A
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Exosome Diagnostics, Inc.:
Prostate Cancer
Gleason Grade
Prostatic Neoplasms

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases