Prostate CancerPRIORITYNCT03082274
Prospective Validation of Prostate Biomarkers for Repeat Biopsy
An observational study of Prostate Cancer, run by MDx Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ConfirmMDx and SelectMDx
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2017to 30 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: ConfirmMDx assay will be utilized to blindly test the needle biopsy cores of the index negative prostate biopsy (all cores) of men about to undergo repeat prostate biopsy. It is postulated that the test may aid in improved patient risk stratification for repeat biopsy, discriminating patients with no cancer/low grade prostate cancer (GS6) who are at sufficiently low risk to avoid repeat biopsy, while also identifying patients at increased risk for clinical significant disease (≥ GS7) who may benefit from early intervention. In this current study, SelectMDx will be used to blindly test urine samples obtained preceding a repeat prostate biopsy to validate the test's ability to predict risk for high-grade disease. The intent is to demonstrate the test's ability to non-invasively stratify those patients at risk for aggressive disease, who require a repeat prostate biopsy, versus those at sufficiently low risk who may avoid unnecessary repeat biopsy.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Validation of Prostate Biomarkers for Repeat Biopsy: The PRIORITY Study
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.
- Conditions
- Prostate Cancer
- Being tested
- ConfirmMDx, SelectMDx
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConfirmMDxDiagnostic test
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.
SelectMDxDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ConfirmMDx; Diagnostic Test: SelectMDx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start31 Mar 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDx Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082274
- Sponsor's protocol ID
- PRIORITY
- Acronym
- PRIORITY
- Status last verified
- Aug 2018
- First submitted
- 28 Feb 2017
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of Prostate Biomarkers for Repeat Biopsy: The PRIORITY Study
- ClinicalTrials.gov ID
- NCT03082274
- Acronym / sponsor ID
- PRIORITY / PRIORITY
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- MDx HealthIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men age 40-85 years with an initial negative prostate biopsy | – | Diagnostic Test: ConfirmMDx, Diagnostic Test: SelectMDxMen age 40 - 85 years of age Previous negative prostate biopsy within 30 months. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ConfirmMDx assay will be utilized to blindly test the needle biopsy cores of the index negative prostate biopsy (all cores) of men about to undergo repeat prostate biopsy. It is postulated that the test may aid in improved patient risk stratification for repeat biopsy, discriminating patients with no cancer/low grade prostate cancer (GS6) who are at sufficiently low risk to avoid repeat biopsy, while also identifying patients at increased risk for clinical significant disease (≥ GS7) who may benefit from early intervention. In this current study, SelectMDx will be used to blindly test urine samples obtained preceding a repeat prostate biopsy to validate the test's ability to predict risk for high-grade disease. The intent is to demonstrate the test's ability to non-invasively stratify those patients at risk for aggressive disease, who require a repeat prostate biopsy, versus those at sufficiently low risk who may avoid unnecessary repeat biopsy.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConfirmMDxConfirmMDx 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 | Men age 40-85 years with an initial negative prostate biopsy |
| SelectMDxSelectMDx 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. | Diagnostic test | Men age 40-85 years with an initial negative prostate biopsy |
Primary outcome
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.
1 secondary outcome
Comparison between clinical and pathological outcomes
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by MDx Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validate ConfirmMDx for Prostate Cancer to predict the outcome of repeat biopsy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.