Prospective Validation of Prostate Biomarkers for Repeat Biopsy (PRIORITY)
|ClinicalTrials.gov Identifier: NCT03082274|
Recruitment Status : Enrolling by invitation
First Posted : March 17, 2017
Last Update Posted : August 17, 2018
Target enrollment is 1000 prospectively enrolled subjects with an initial negative biopsy scheduled for repeat biopsy.
Subjects must have had their negative index prostate biopsy procedure within 30 months of being scheduled for their repeat biopsy.
All enrolled subjects will have all core tissues from the initial negative biopsy blinded and tested with the assay.
All subjects will have serum and plasma samples obtained prior to DRE, and a urine sample collected immediately following DRE but in advance of the repeat biopsy; samples will be blinded and sent to MDxHealth for evaluation.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Diagnostic Test: ConfirmMDx Diagnostic Test: SelectMDx|
|Study Type :||Observational|
|Actual Enrollment :||1000 participants|
|Official Title:||Prospective Validation of Prostate Biomarkers for Repeat Biopsy: The PRIORITY Study|
|Actual Study Start Date :||March 31, 2017|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
Men age 40-85 years with an initial negative prostate biopsy
Men age 40 - 85 years of age Previous negative prostate biopsy within 30 months.
Diagnostic Test: ConfirmMDx
ConfirmMDx is a molecular diagnostic assay which utilizes DNA isolated from biopsy tissues to determine if aberrant DNA methylation is occurring in three genes: GSTP1, RASSF1 and APC. ConfirmMDx is currently available to clinicians for use in cancer-negative extended-core biopsies to determine if occult cancer is present in the prostate.
Diagnostic Test: SelectMDx
SelectMDx for Prostate Cancer is a reverse-transcription PCR (RT-PCR) assay performed on post-DRE, first-void urine specimens from patients with clinical risk factors for prostate cancer, who are being considered for biopsy. The test measures the mRNA levels of the DLX1 and HOXC6 biomarkers, using KLK3 as internal reference gene, to aid in patient selection for prostate biopsy.
- Validate ConfirmMDx for Prostate Cancer to predict the outcome of repeat biopsy [ Time Frame: 1 year ]
The primary objectives of this prospective, multi-center study are twofold:
- Validate use of the ConfirmMDx for Prostate Cancer to predict the outcome of a repeat biopsy in men with a previous negative prostate biopsy using tissue.
- Validate use of the SelectMDx for Prostate Cancer to predict the outcome of a repeat biopsy in men with a previous negative prostate biopsy using urine.
- Comparison between clinical and pathological outcomes [ Time Frame: 1 year ]
Subset analyses conducted in appropriate groups, such as patients with available data from radical prostatectomy, and correlate this data with the ConfirmMDx and SelectMDx results.
- Evaluate rate of cancer detection on repeat biopsy and associated complications.
- Evaluate the findings of MRI fusion biopsy with standard 12 core TRUS guided biopsy (if available).
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082274
|United States, California|
|Irvine, California, United States, 92618|