CompletedNCT02702856Updated Mar 9, 2016

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

An observational study in Prostate Cancer, sponsored by Exosome Diagnostics, Inc.. Completed. Open to male participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-09.

Sponsored by Exosome Diagnostics, Inc. · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 2,000
Ages: 50 Years and older
Sex: Male

Study 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.

Read the 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.

Conditions studied

Prostate Cancer

Browse trials for

Prostatic Neoplasms 6,484

Keywords

Prostate Cancer
Gleason Grade
Prostatic Neoplasms

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's enrollment of 2,000 is above the median of 200 across 1,200 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Exosome Diagnostics, Inc. is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years and older
Sexes eligible: Male
Accepts healthy volunteers: Yes
Sampling method: Probability sample

Study population

Community Sample

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.
The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents.

Exclusion criteria

Exclusion Criteria:

Use of medications or hormones that are known to affect serum PSA 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 (BPH) or lower urinary track symptoms within 6 months of study enrollment.
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.
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.
No known hepatitis (all types) and/or HIV documented in patient's medical record.
Patients with history of concurrent renal/bladder tumors within 6 months of study enrollment.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 2,000 participants (actual)
Patient registry: No
Biospecimen retention: Samples without dna

Groups and cohorts

Men screened for prostate cancer
Other: ExoIntelliScore Prostate

Interventions

OtherExoIntelliScore Prostate

What researchers measure

Primary outcomes

Correlate an exosome gene expression signature with the presence or absence of high grade prostate cancer in the prostate needle biopsy.
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%.
Time frame: one year

Study locations

No study locations are listed for this record.

References and documents

Publications

Kretschmer A, Tutrone R, Alter J, Berg E, Fischer C, Kumar S, Torkler P, Tadigotla V, Donovan M, Sant G, Skog J, Noerholm M. Pre-diagnosis urine exosomal RNA (ExoDx EPI score) is associated with post-prostatectomy pathology outcome. World J Urol. 2022 Apr;40(4):983-989. doi: 10.1007/s00345-022-03937-0. Epub 2022 Jan 27. PubMed 35084544 ↗

Individual participant data

Plan to share: Yes

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2014, a primary completion of Apr 2015 and a completion of Jun 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 3, 2016
First posted: Mar 9, 2016
Start: May 2014
Primary completionActual: Apr 2015
CompletionActual: Jun 2015
Last update: Mar 9, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Mar 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02702856
Lead sponsor: Exosome Diagnostics, Inc.
Responsible party: Sponsor
First posted: Mar 9, 2016
Start date: May 2014
Primary completion: Apr 2015
Completion: Jun 2015
Last update: Mar 9, 2016

Study contacts

Roger Tun

study director · Exosome Diagnostics, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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