Prostate Cancer Clinical Trial
— PRIORITYOfficial title:
Prospective Validation of Prostate Biomarkers for Repeat Biopsy: The PRIORITY Study
Verified date | August 2018 |
Source | MDx Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 1000 |
Est. completion date | December 30, 2019 |
Est. primary completion date | December 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 40 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Males, aged 40 years to 85, who underwent a previous cancer-negative prostate biopsy within 30 months of being scheduled for a repeat biopsy. - The initial TRUS guided negative prostate biopsy must have collected a minimum of 10 tissue cores and sections from all prostate biopsy cores collected by the physician must be submitted to MDxHealth in order to allow for full comprehensive testing/evaluation of all the sections of the patient's prostate prior to the scheduled repeat biopsy. - Minimum tissue volume criteria of 20 microns of prostate biopsy core tissue is available (40 microns preferable). - Previous biopsy histology may include the presence of high-grade prostatic intraepithelial neoplasia (HGPIN), proliferative inflammatory atrophy (PIA), glandular inflammation, atypical small acinar proliferation (ASAP) or atypical cells. - Tissue was extracted using standard TRUS guided biopsy core extraction (and not transurethral resection of the prostate (TURP). - Pre-DRE serum sample, pre-DRE plasma sample, and Post-DRE urine sample to be collected in advance of the repeat biopsy. Samples can be collected within three months of the scheduled repeat biopsy, up until the day of, but prior to, the procedure. Exclusion Criteria: - Patient who has undergone previously testing by ConfirmMDx from the same biopsy - Patients with prior diagnosis of prostate cancer in any previous biopsy. - Patients with a limited life expectancy and generally not considered for a repeat Tissue extracted using transurethral resection of the prostate (TURP) procedures - Patients with a history of cancer (except basal cell carcinoma) |
Country | Name | City | State |
---|---|---|---|
United States | MDxHealth | Irvine | California |
Lead Sponsor | Collaborator |
---|---|
MDx Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Validate ConfirmMDx for Prostate Cancer to predict the outcome of repeat biopsy | 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. |
1 year | |
Secondary | Comparison between clinical and pathological outcomes | 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). |
1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Active, not recruiting |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |