Prostate CancerNCT04357717
ExoDx Prostate Evaluation in Prior Negative Prostate Biopsy Setting
An observational study of Prostate Cancer, run by Exosome Diagnostics, Inc. at 2 sites in United States.
Trial summary
The study is designed to confirm the performance of the ExoDx Prostate test in prior negative biopsy patients now presenting for a repeat prostate biopsy. Note: ExoDx Prostate test results are collected for correlation to biopsy results and are not disclosed to the physician or study subject. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ExoDx Prostate
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Mar 2020to 1 Sep 2021
- 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 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men, aged 50yrs or older with an elevated PSA between 2-10ng/ml and at least one prior negative prostate biopsy
Who may be able to join
- 50+ years of age
- Clinical suspicion for prostate cancer
- Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
- At least one (1) prior negative prostate biopsy
Who cannot join
- Use of medications or hormones that are known to affect serum PSA levels within 3-6 months of study enrollment including 5-alpha-reductase inhibitors used in the treatment of an enlarged prostate gland (benign prostatic hyperplasia). Drugs in this class are finasteride (Proscar, Propecia) and dutasteride (Avodart).
- Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
- History of prostate cancer.
- History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary track symptoms within 6 months of study enrollment.
- No known hepatitis status (all types) and/or HIV documented in patient's medical record.
- Patients with history of concurrent renal/bladder tumors.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Chesapeake Urology Research Associates
Baltimore, Maryland, 21204
New Jersey Urology
Voorhees Township, New Jersey, 08043
About this study
Official title: Clinical Evaluation of ExoDx™ Prostate (IntelliScore) in Men With Prior Negative Prostate Biopsy Presenting for a Repeat Biopsy
The study is designed to confirm the performance of the ExoDx Prostate test in prior negative biopsy patients now presenting for a repeat prostate biopsy.
Note: ExoDx Prostate test results are collected for correlation to biopsy results and are not disclosed to the physician or study subject.
Read the detailed description
Primary Endpoint:
Evaluate the correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort.
Secondary Endpoints (exploratory):
- Evaluate the clinical performance of the ExoDx Prostate test at the cut-point of 15.6 defined for the initial biopsy patient cohort.
- Associate ExoDx Prostate test results with other ancillary studies including the use of radiographic imaging (e.g. multiparametric MRI).
- Evaluate the correlation of ExoDx Prostate as a function of risk. It is known that a higher ExoDx Prostate score correlates to a higher risk of finding prostate cancer, including HGPC, upon biopsy.
- Evaluate ExoDx Prostate with and without inclusion of standard of care parameters such as PSA, ethnicity, DRE, age and family history.
- Conditions
- Prostate Cancer
- Being tested
- ExoDx Prostate
- Keywords
- exosome, ExoDx Prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExoDx ProstateDiagnostic test
Urine-based biomarker tool to support decision to biopsy in patients with PSA between 2-10ng/ml
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start15 Mar 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Why it stopped: project reprioritization
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exosome Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357717
- Sponsor's protocol ID
- ECT2018-001
- Status last verified
- Mar 2022
- First submitted
- 20 Apr 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of ExoDx™ Prostate (IntelliScore) in Men With Prior Negative Prostate Biopsy Presenting for a Repeat Biopsy
- ClinicalTrials.gov ID
- NCT04357717
- Acronym / sponsor ID
- ECT2018-001
- Conditions
- Prostate Cancer
- Keywords
- exosome, ExoDx Prostate
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: project reprioritization
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Exosome Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 22 Apr 2020 (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.
The study is designed to confirm the performance of the ExoDx Prostate test in prior negative biopsy patients now presenting for a repeat prostate biopsy.
Note: ExoDx Prostate test results are collected for correlation to biopsy results and are not disclosed to the physician or study subject.
Detailed description
Primary Endpoint:
Evaluate the correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort.
Secondary Endpoints (exploratory):
- Evaluate the clinical performance of the ExoDx Prostate test at the cut-point of 15.6 defined for the initial biopsy patient cohort.
- Associate ExoDx Prostate test results with other ancillary studies including the use of radiographic imaging (e.g. multiparametric MRI).
- Evaluate the correlation of ExoDx Prostate as a function of risk. It is known that a higher ExoDx Prostate score correlates to a higher risk of finding prostate cancer, including HGPC, upon biopsy.
- Evaluate ExoDx Prostate with and without inclusion of standard of care parameters such as PSA, ethnicity, DRE, age and family history.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men, aged 50yrs or older with an elevated PSA between 2-10ng/ml and at least one prior negative prostate biopsy
Key inclusion criteria (4 listed)
- 50+ years of age
- Clinical suspicion for prostate cancer
- Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
- At least one (1) prior negative prostate biopsy
Key exclusion criteria (6 listed)
- Use of medications or hormones that are known to affect serum PSA levels within 3-6 months of study enrollment including 5-alpha-reductase inhibitors used in the treatment of an enlarged prostate gland (benign prostatic hyperplasia). Drugs in this class are finasteride (Proscar, Propecia) and dutasteride (Avodart).
- Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
- History of prostate cancer.
- History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary track symptoms within 6 months of study enrollment.
- No known hepatitis status (all types) and/or HIV documented in patient's medical record.
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 |
|---|---|---|
| ExoDx ProstateUrine-based biomarker tool to support decision to biopsy in patients with PSA between 2-10ng/ml | Diagnostic test | – |
Primary outcome
Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort.
Time frame: 6 months
Results and safety
The study was stopped early (reason given: project reprioritization). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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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.
2 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 Exosome Diagnostics, Inc. at 2 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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: project reprioritization). 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?
Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in a prior negative repeat biopsy patient cohort. (time frame: 6 months). 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 31 Mar 2022.