Prostate CancerPASCUALNCT02250313
PASCUAL (Prostate Assay Specific Clinical Utility at Launch) Study
An observational study of Prostate Cancer, run by MDx Health at 15 sites in United States.
Trial summary
The main hypothesis of this study is to demonstrate that the use of the ConfirmMDx for Prostate Cancer test in previously biopsied patients improves urologists' patient management by reducing unnecessary repeat biopsies, attendant procedure costs, and potential adverse events in men being considered for a repeat… Read more about this study
- Who is it for?
- Ages 40 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- How many people
- 600 participants
- Where
- 15 sitesUnited States
- Study dates
- Sep 2014to Jul 2018
- 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 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males aged 40 to 75 years old* that underwent a previous cancer-negative prostate biopsy within 15 months and being considered for a repeat biopsy due to persistent or elevated cancer-risk factors
Who may be able to join
- Males aged 40 to 75 years old* that underwent a previous cancer-negative prostate biopsy within 15 months and being considered for a repeat biopsy due to persistent or elevated cancer-risk factors
- The previous negative prostate biopsy must have collected a minimum of 8 tissue cores and remaining FFPE tissue from all cores should be available for testing
- Minimum tissue volume criteria of 20 microns of prostate biopsy core tissue should be available (40 microns preferable)
- The presence of HGPIN (high-grade prostatic intraepithelial neoplasia), PIA (proliferative inflammatory atrophy), or glandular inflammation reported in the first biopsy histopathology report is acceptable for entry.
Who cannot join
- Prior diagnosis of prostate cancer or cellular atypia suspicious for cancer (ASAP) in a previous biopsy histology report.
- Patients being managed by Active Surveillance for low stage prostate cancer
- Men greater than 75 years old (generally not considered for repeat biopsy)
- Most recent biopsy was a saturation biopsy (> 24 tissue cores).
- Tissue extracted using transurethral resection of the prostate (TURP) procedures rather than standard patterned biopsy core extraction.
- Subjects who had been previously tested with ConfirmMDx.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Urology Clinics of North Texas, PLLC
Dallas, Texas, 75231
Urology Center of Colorado
Denver, Colorado, 80211
Urology Centers of Alabama
Homewood, Alabama, 35209
First Urology, PSC
Jeffersonville, Indiana, 47130
Lancaster Urology
Lancaster, Pennsylvania, 17604
Carolina Urological Research Center
Myrtle Beach, South Carolina, 29572
Urology Associates, P.C.
Nashville, Tennessee, 37209
Urology San Antonio Research
San Antonio, Texas, 78229
Genesis Research LLC
San Diego, California, 92123
Regional Urology, LLC
Shreveport, Louisiana, 71106
Oregon Urology Institute
Springfield, Oregon, 97477
Associated Medical Professionals of NY
Syracuse, New York, 13210
Skyline Urology
Torrance, California, 90505
Chesapeake Urology Research Associates
Towson, Maryland, 21204
Michigan Institute of Urology
Troy, Michigan, 48084
About this study
The main hypothesis of this study is to demonstrate that the use of the ConfirmMDx for Prostate Cancer test in previously biopsied patients improves urologists' patient management by reducing unnecessary repeat biopsies, attendant procedure costs, and potential adverse events in men being considered for a repeat procedure.
Read the detailed description
The results of the study will reveal the clinical utility of this test by analyzing the physicians' use of negative or positive assays compared to patients managed using SOC methods without assay findings. The repeat biopsy rate at 12 months from study entry will be used for the primary endpoint analysis. All patients will be followed for 24 months from the date of the previous negative biopsy to evaluate an extended period of observation to track repeat biopsies and cancer detection.
The primary objective of this study is to demonstrate a lower repeat biopsy rate by using the negative results of ConfirmMDx for Prostate Cancer in practice rather than current SOC. All patients will have the tissue from their previous negative biopsy tested with the assay. Only data from Cases (informed of ConfirmMDx assay results) and Controls (blinded of the ConfirmMDx assay result) patients with negative test results will be used for the primary objective.
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Case | All patients will have the tissue from their previous negative biopsy tested with the assay. Cases are defined as those subjects who receive the ConfirmMDx assay results. | |
| Control | All patients will have the tissue from their previous negative biopsy tested with the assay. Controls are defined as subjects who will be blinded to the ConfirmMDx assay results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to demonstrate the clinical utility of the ConfirmMDx test
The primary objective is to demonstrate a lower repeat biopsy rate by using the negative results of ConfirmMDx for Prostate Cancer in practice rather than current SOC.
Measured: 2 years
Secondary outcomes (6)
Compare rebiopsy rates assay negative results in cases and controls
Comparison of rebiopsy rates of Cases and Controls with assay negative results at the end of follow up of 24 months from the date of the previous biopsy.
Measured: 2 years
Compare rebiopsy rates in assay positive group vs standard of care
Comparison of rebiopsy rates in assay positive results group vs. SOC (blinded) positive assay group.
Measured: 2 years
Compare rebiopsy rates of case and controls
Comparison of overall rates of rebiopsies of the entire Case vs. Control Cohorts
Measured: 2 years
Analyse cancer detection rates
Analysis of cancer detection rates in ConfirmMDx positive and negative arms versus those of Controls
Measured: 2 years
Evaluate clinical utility and cost savings by using the ConfirmMDx test
Evaluate clinical resource utilization, medical complications, and cost impact across groups
Measured: 2 years
Compare rebiopsy rates assay positive results in cases and controls
Evaluate prostate cancer detection rates after repeat biopsy in the Case and Controls positive and negative groups at the end of 24 months after the previous negative biopsy date.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2018
- Study completionJul 2018
Why it stopped: Pending final analysis for termination
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-control
- Time perspective
- Prospective
- Enrolment
- 600 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
- NCT02250313
- Sponsor's protocol ID
- PASCUAL
- Acronym
- PASCUAL
- Status last verified
- Jul 2018
- First submitted
- 16 Sep 2014
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PASCUAL (Prostate Assay Specific Clinical Utility at Launch) Study
- ClinicalTrials.gov ID
- NCT02250313
- Acronym / sponsor ID
- PASCUAL / PASCUAL
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Pending final analysis for termination
- Enrolment
- 600 participants (actual)
- Lead sponsor
- MDx HealthIndustry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 26 Sep 2014 (estimated)
- 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.
The main hypothesis of this study is to demonstrate that the use of the ConfirmMDx for Prostate Cancer test in previously biopsied patients improves urologists' patient management by reducing unnecessary repeat biopsies, attendant procedure costs, and potential adverse events in men being considered for a repeat procedure.
Detailed description
The results of the study will reveal the clinical utility of this test by analyzing the physicians' use of negative or positive assays compared to patients managed using SOC methods without assay findings. The repeat biopsy rate at 12 months from study entry will be used for the primary endpoint analysis. All patients will be followed for 24 months from the date of the previous negative biopsy to evaluate an extended period of observation to track repeat biopsies and cancer detection.
The primary objective of this study is to demonstrate a lower repeat biopsy rate by using the negative results of ConfirmMDx for Prostate Cancer in practice rather than current SOC. All patients will have the tissue from their previous negative biopsy tested with the assay. Only data from Cases (informed of ConfirmMDx assay results) and Controls (blinded of the ConfirmMDx assay result) patients with negative test results will be used for the primary objective.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | –All patients will have the tissue from their previous negative biopsy tested with the assay. Cases are defined as those subjects who receive the ConfirmMDx assay results. |
| Control | – | –All patients will have the tissue from their previous negative biopsy tested with the assay. Controls are defined as subjects who will be blinded to the ConfirmMDx assay results. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males aged 40 to 75 years old* that underwent a previous cancer-negative prostate biopsy within 15 months and being considered for a repeat biopsy due to persistent or elevated cancer-risk factors
Key inclusion criteria (4 listed)
- Males aged 40 to 75 years old* that underwent a previous cancer-negative prostate biopsy within 15 months and being considered for a repeat biopsy due to persistent or elevated cancer-risk factors
- The previous negative prostate biopsy must have collected a minimum of 8 tissue cores and remaining FFPE tissue from all cores should be available for testing
- Minimum tissue volume criteria of 20 microns of prostate biopsy core tissue should be available (40 microns preferable)
- The presence of HGPIN (high-grade prostatic intraepithelial neoplasia), PIA (proliferative inflammatory atrophy), or glandular inflammation reported in the first biopsy histopathology report is acceptable for entry.
Key exclusion criteria (6 listed)
- Prior diagnosis of prostate cancer or cellular atypia suspicious for cancer (ASAP) in a previous biopsy histology report.
- Patients being managed by Active Surveillance for low stage prostate cancer
- Men greater than 75 years old (generally not considered for repeat biopsy)
- Most recent biopsy was a saturation biopsy (> 24 tissue cores).
- Tissue extracted using transurethral resection of the prostate (TURP) procedures rather than standard patterned biopsy core extraction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary objective is to demonstrate the clinical utility of the ConfirmMDx test
Time frame: 2 years
The primary objective is to demonstrate a lower repeat biopsy rate by using the negative results of ConfirmMDx for Prostate Cancer in practice rather than current SOC.
6 secondary outcomes
Compare rebiopsy rates assay negative results in cases and controls
Time frame: 2 years
Compare rebiopsy rates in assay positive group vs standard of care
Time frame: 2 years
Compare rebiopsy rates of case and controls
Time frame: 2 years
Analyse cancer detection rates
Time frame: 2 years
Evaluate clinical utility and cost savings by using the ConfirmMDx test
Time frame: 2 years
Compare rebiopsy rates assay positive results in cases and controls
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Pending final analysis for termination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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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.
15 sites 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 15 sites 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
The study was stopped early (reason given: Pending final analysis for termination). 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?
The primary objective is to demonstrate the clinical utility of the ConfirmMDx test (time frame: 2 years). 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 26 Jul 2018.