Clinical trial NCT02702856: Clinical Validation of a Urinary Exosome Gene Signature in Men Presenting for Suspicion of Prostate Cancer
Official title: Clinical Validation of a Urinary Exosome Gene Signature in Men Presenting for Suspicion of Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Gleason Grade
Prostatic Neoplasms
Lead sponsor: Exosome Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-09
Enrollment: 2000
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community Sample

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.

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.

Eligibility 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.

Primary outcomes:
measure: Correlate an exosome gene expression signature with the presence or absence of high grade prostate cancer in the prostate needle biopsy.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Exosome Diagnostics, Inc.
name: Roger Tun
role: STUDY_DIRECTOR
References:
citation: 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.