Decision Impact Trial of the ExoDx Prostate (IntelliScore)

NCT03235687 | Unknown

• 1 other identifier: ECT2017-002
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer of the Prostate

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cohort A

EXPERIMENTAL

Patients randomized to Cohort A will receive ExoDx Prostate (IntelliScore) test results along with a post-ExoDx Prostate (IntelliScore) test result questionnaire to evaluate impact of test results in the biopsy decision process, utility, ease of understanding and work-flow implementation.

Diagnostic Test: ExoDx Prostate (IntelliScore)

Cohort B

NO INTERVENTION

Patients randomized to Cohort B will proceed with conventional standard of care.

Interventions

ExoDx Prostate (IntelliScore) DIAGNOSTIC_TEST

ExoDx Prostate (IntelliScore) is a non-invasive, urinary 3-gene expression validated test in which the results of the assay are adjunctive to the ordering physician's clinical judgment and work-up of the patient in the determination of whether a prostate needle biopsy is necessary. The ExoDx Prostate (IntelliScore) was clinically validated to discriminate patients with higher grade prostate cancer from those with more indolent lower grade cancer and benign disease.

Also known as: EPI

Cohort A

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Must be male to screen for prostate cancer
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Exosome Diagnostics, Inc.: lead
• CareFirst BlueCross BlueShield: collaborator
• Chesapeake Urology Research Associates: collaborator

Study Sites (1)

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

Location

Related Publications (3)

• 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. 2020 Dec;23(4):607-614. doi: 10.1038/s41391-020-0237-z. Epub 2020 May 7.

  PMID: 32382078 RESULT

• Tutrone R, Lowentritt B, Neuman B, Donovan MJ, Hallmark E, Cole TJ, Yao Y, Biesecker C, Kumar S, Verma V, Sant GR, Alter J, Skog J. ExoDx prostate test as a predictor of outcomes of high-grade prostate cancer - an interim analysis. Prostate Cancer Prostatic Dis. 2023 Sep;26(3):596-601. doi: 10.1038/s41391-023-00675-1. Epub 2023 May 16.

  PMID: 37193776 DERIVED

• 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.

  PMID: 35084544 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Roger Tun

  Exosome Diagnostics, Inc.

  STUDY DIRECTOR

• Ronald F Tutrone, MD

  Chesapeake Urology Research Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized blinded, shared decision-impact and health-economic assessment study. 1000 appropriately screened consecutive patients seen during planning for a prostate biopsy will be enrolled. 500 patients will be randomized (blinded) to have the ExoDx Prostate (IntelliScore) test (Cohort A) and 500 (Cohort B) will proceed with conventional standard of care. At time of enrollment, neither the patient nor the urologist will be made aware of whether the patient will have an ExoDx Prostate (IntelliScore) test as part of their work-up. Cohort A EPI test results will be sent to the urologist for assessment and ultimately shared with the patient.

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 1, 2017
• Study Start: July 19, 2017
• Primary Completion: September 1, 2018
• Study Completion: September 29, 2023
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)