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
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Prostate||Diagnostic Test: ExoDx Prostate (IntelliScore)||Not Applicable|
- 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.
- Compare performance of both the ExoDx Prostate(IntelliScore) 15.6 and 20 cut-points with respect to the biopsy decision process.
- Assess physician satisfaction with the ExoDx Prostate(IntelliScore) report including test result presentation, graphics and interpretation.
- Assess urologist / patient satisfaction for ease of understanding test results and role on biopsy decision process.
- Determine the medical economic impact of the ExoDx Prostate(IntelliScore) test in the prostate biopsy decision process.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|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)|
|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|
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.
- 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.
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
|United States, Maryland|
|Chesapeake Urology Research Associates|
|Towson, Maryland, United States, 21204|
|Study Director:||Roger Tun||Exosome Diagnostics, Inc.|
|Principal Investigator:||Ronald F Tutrone, MD||Chesapeake Urology Research Associates|