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Trial record 89 of 123 for:    prostate cancer AND prostate cancer screening | ( Map: United States )

Decision Impact Trial of the ExoDx Prostate (IntelliScore)

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ClinicalTrials.gov Identifier: NCT03235687
Recruitment Status : Active, not recruiting
First Posted : August 1, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
CareFirst BlueCross BlueShield
Chesapeake Urology Research Associates
Information provided by (Responsible Party):
Exosome Diagnostics, Inc.

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.

Condition or disease Intervention/treatment Phase
Cancer of the Prostate Diagnostic Test: ExoDx Prostate (IntelliScore) Not Applicable

Detailed Description:

Primary Objective(s)

  1. Evaluate performance of the ExoDx Prostate(IntelliScore) (EPI) to reduce the number of initial prostate biopsies by greater than or equal to 15% for men with an elevated Prostate-Specific Antigen 2-10ng/mL presenting for a biopsy in consultation with their urologist.
  2. Compare performance of both the ExoDx Prostate(IntelliScore) 15.6 and 20 cut-points with respect to the biopsy decision process.
  3. Assess physician satisfaction with the ExoDx Prostate(IntelliScore) report including test result presentation, graphics and interpretation.
  4. Assess urologist / patient satisfaction for ease of understanding test results and role on biopsy decision process.

Secondary Objectives

  1. Determine the medical economic impact of the ExoDx Prostate(IntelliScore) test in the prostate biopsy decision process.
  2. Correlation of the ExoDx Prostate(IntelliScore) score with the actual biopsy result by utilizing the Receiver Operating Characteristic of the Area Under Curve for discriminating high-grade (greater than or equal to Gleason Score 7, International Society of Urological Pathology 2 and 3) from low-grade (Gleason Score 6, International Society of Urological Pathology 1) and benign disease on initial prostate needle biopsy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Screening
Official Title: A Prospective, Randomized Blinded, Shared Decision Impact Trial of the ExoDx Prostate (IntelliScore), EPI Test, in Men Presenting for Initial Biopsy.
Actual Study Start Date : July 19, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 29, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort A
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)
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.
Other Name: EPI

No Intervention: Cohort B
Patients randomized to Cohort B will proceed with conventional standard of care.



Primary Outcome Measures :
  1. Evaluate performance of the ExoDx Prostate(IntelliScore) [ Time Frame: 6 Months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Must be male to screen for prostate cancer
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 50 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

Exclusion Criteria:

  • 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.

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): NCT03235687


Locations
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United States, Maryland
Chesapeake Urology Research Associates
Towson, Maryland, United States, 21204
Sponsors and Collaborators
Exosome Diagnostics, Inc.
CareFirst BlueCross BlueShield
Chesapeake Urology Research Associates
Investigators
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Study Director: Roger Tun Exosome Diagnostics, Inc.
Principal Investigator: Ronald F Tutrone, MD Chesapeake Urology Research Associates

Publications of Results:
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Responsible Party: Exosome Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT03235687     History of Changes
Other Study ID Numbers: ECT2017-002
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases