Urologic CancerNCT04720599
Clinical Evaluation of ExoDx Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy
An observational study of Urologic Cancer, run by Exosome Diagnostics, Inc. at 3 sites in 2 countries.
Trial summary
The study described here is being conducted to prospectively confirm the performance of the ExoDx Prostate gene expression assay in patients presenting for an initial prostate biopsy and support of CE-marking the test for a European Union Launch. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Urologic Cancer
- What is being tested?
- ExoDx Prostate(IntelliScore)
- How many people
- 120 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jun 2020to 1 Jun 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
- Adult, Older adult
Study population: - Men, aged 50yrs or older with an elevated PSA between 2-10ng/ml scheduled for an initial biopsy
Who may be able to join
- Clinical suspicion for prostate cancer
- Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
- Scheduled for a initial prostate biopsy
Who cannot join
- 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.
- Known hepatitis status (all types) and/or HIV documented in patient's medical record.
- Patients with history of concurrent renal/bladder tumors.
- Prior MRI used in the decision to biopsy
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
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 Presenting for Initial Prostate Biopsy
The study described here is being conducted to prospectively confirm the performance of the ExoDx Prostate gene expression assay in patients presenting for an initial prostate biopsy and support of CE-marking the test for a European Union Launch.
- Conditions
- Urologic Cancer
- Being tested
- ExoDx Prostate(IntelliScore)
- Keywords
- exosome, ExoDx Prostate
- Medical subject headings
- Urologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExoDx Prostate(IntelliScore)Diagnostic test
Also called EPI, EPI-CE
The ExoDx Prostate test result supports the biopsy decision process by stratifying patients based on risk for high grade prostate cancer
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 an initial biopsy patient cohort.
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 posted22 Jan 2021
- Study start1 Jun 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urologic 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exosome Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mikkel Noerholm, Study director, Exosome Diagnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720599
- Sponsor's protocol ID
- ECT2020-002
- Status last verified
- Dec 2020
- First submitted
- 20 Jan 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD can be shared on an individual basis. Please reach out for more information.
Publications
Kretschmer A, Kajau H, Margolis E, Tutrone R, Grimm T, Trottmann M, Stief C, Stoll G, Fischer CA, Flinspach C, Albrecht A, Meyer L, Priewasser T, Enderle D, Muller R, Torkler P, Alter J, Skog J, Noerholm M. Validation of a CE-IVD, urine exosomal RNA expression assay for risk assessment of prostate cancer prior to biopsy. Sci Rep. 2022 Mar 21;12(1):4777. doi: 10.1038/s41598-022-08608-z.
PubMed 35314720Kretschmer A, Tutrone R, Alter J, Berg E, Fischer C, Kumar S, Torkler P, Tadigotla V, Donovan M, Sant G, Skog J, Noerholm M. Pre-diagnosis urine exosomal RNA (ExoDx EPI score) is associated with post-prostatectomy pathology outcome. World J Urol. 2022 Apr;40(4):983-989. doi: 10.1007/s00345-022-03937-0. Epub 2022 Jan 27.
PubMed 35084544
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of ExoDx™ Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy
- ClinicalTrials.gov ID
- NCT04720599
- Acronym / sponsor ID
- ECT2020-002
- Conditions
- Urologic Cancer
- Keywords
- exosome, ExoDx Prostate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Exosome Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 22 Jan 2021 (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 described here is being conducted to prospectively confirm the performance of the ExoDx Prostate gene expression assay in patients presenting for an initial prostate biopsy and support of CE-marking the test for a European Union Launch.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- - Men, aged 50yrs or older with an elevated PSA between 2-10ng/ml scheduled for an initial biopsy
Key inclusion criteria (3 listed)
- Clinical suspicion for prostate cancer
- Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
- Scheduled for a initial prostate biopsy
Key exclusion criteria (6 listed)
- 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.
- Known hepatitis status (all types) and/or HIV documented in patient's medical record.
- Patients with history of concurrent renal/bladder tumors.
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 Prostate(IntelliScore)Also: EPI, EPI-CEThe ExoDx Prostate test result supports the biopsy decision process by stratifying patients based on risk for high grade prostate cancer | Diagnostic test | – |
Primary outcome
Correlation of the ExoDx Prostate test results with the outcome of prostate biopsies in an initial biopsy patient cohort.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Derived from this study: PubMed 35314720Kretschmer A, Kajau H, Margolis E, Tutrone R, Grimm T, Trottmann M, Stief C, Stoll G, Fischer CA, Flinspach C, Albrecht A, Meyer L, Priewasser T, Enderle D, Muller R, Torkler P, Alter J, Skog J, Noerholm M. Validation of a CE-IVD, urine exosomal RNA expression assay for risk assessment of prostate cancer prior to biopsy. Sci Rep. 2022 Mar 21;12(1):4777. doi: 10.1038/s41598-022-08608-z.
- Derived from this study: PubMed 35084544Kretschmer A, Tutrone R, Alter J, Berg E, Fischer C, Kumar S, Torkler P, Tadigotla V, Donovan M, Sant G, Skog J, Noerholm M. Pre-diagnosis urine exosomal RNA (ExoDx EPI score) is associated with post-prostatectomy pathology outcome. World J Urol. 2022 Apr;40(4):983-989. doi: 10.1007/s00345-022-03937-0. Epub 2022 Jan 27.
- Individual participant dataSharing planned: Yes. IPD can be shared on an individual basis. Please reach out for more information.
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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.
Mikkel Noerholm study director
Exosome Diagnostics, Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Cancer, run by Exosome Diagnostics, Inc. at 3 sites in 2 countries.
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 3 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: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 an initial biopsy patient cohort. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04720599, which also lists 2 linked publications.
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 30 Sep 2021.