Cancer of the ProstateNCT03235687
Decision Impact Trial of the ExoDx Prostate (IntelliScore)
A study testing ExoDx Prostate (IntelliScore) in people with Cancer of the Prostate, run by Exosome Diagnostics, Inc. at 1 site in United States.
Trial summary
The purpose of this research study is to investigate the utility of a validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy. 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
- Cancer of the Prostate
- What is being tested?
- ExoDx Prostate (IntelliScore)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2017to 29 Sep 2023
- Phase
- Interventional
- 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
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
- No clinical history of a prior negative biopsy
Who cannot join
- History of prior prostate biopsy.
- Use of medications or hormones that are known to affect serum Prostate-specific antigen levels within 3-6 months of study enrollment.
- 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 (Benign Prostatic Hyperplasia) or lower urinary track symptoms within 6 months of study enrollment.
- Known hepatitis (all types) and/or HIV documented in patient's medical record.
- Patients with history of concurrent renal/bladder tumors.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chesapeake Urology Research Associates
Towson, Maryland, 21204
About this study
Official title: A Prospective, Randomized Blinded, Shared Decision Impact Trial of the ExoDx Prostate (IntelliScore), EPI Test, in Men Presenting for Initial Biopsy.
The purpose of this research study is to investigate the utility of a validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy.
Read the detailed description
Primary Objective(s)
- Evaluate performance of the ExoDx Prostate(IntelliScore) (EPI) to reduce the number of initial prostate biopsies by greater than or equal to 15% for men with an elevated Prostate-Specific Antigen 2-10ng/mL presenting for a biopsy in consultation with their urologist.
- Compare performance of both the ExoDx Prostate(IntelliScore) 15.6 and 20 cut-points with respect to the biopsy decision process.
- Assess physician satisfaction with the ExoDx Prostate(IntelliScore) report including test result presentation, graphics and interpretation.
- Assess urologist / patient satisfaction for ease of understanding test results and role on biopsy decision process.
Secondary Objectives
- Determine the medical economic impact of the ExoDx Prostate(IntelliScore) test in the prostate biopsy decision process.
- Correlation of the ExoDx Prostate(IntelliScore) score with the actual biopsy result by utilizing the Receiver Operating Characteristic of the Area Under Curve for discriminating high-grade (greater than or equal to Gleason Score 7, International Society of Urological Pathology 2 and 3) from low-grade (Gleason Score 6, International Society of Urological Pathology 1) and benign disease on initial prostate needle biopsy.
- Conditions
- Cancer of the Prostate
- Being tested
- ExoDx Prostate (IntelliScore)
- 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 Prostate (IntelliScore)Diagnostic test
Also called EPI
ExoDx Prostate (IntelliScore) is a non-invasive, urinary 3-gene expression validated test in which the results of the assay are adjunctive to the ordering physician's clinical judgment and work-up of the patient in the determination of whether a prostate needle biopsy is necessary. The ExoDx Prostate (IntelliScore) was clinically validated to discriminate patients with higher grade prostate cancer from those with more indolent lower grade cancer and benign disease.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Patients randomized to Cohort A will receive ExoDx Prostate (IntelliScore) test results along with a post-ExoDx Prostate (IntelliScore) test result questionnaire to evaluate impact of test results in the biopsy decision process, utility, ease of understanding and work-flow implementation. Receives: Diagnostic Test: ExoDx Prostate (IntelliScore) |
| Cohort B | No intervention | Patients randomized to Cohort B will proceed with conventional standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate performance of the ExoDx Prostate(IntelliScore)
Evaluate performance of the ExoDx Prostate(IntelliScore) to reduce the number of initial prostate biopsies by greater than or equal to 15% for men with an elevated prostate specific antigen between 2-10ng/mL presenting for a biopsy in consultation with their urologist.
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 posted1 Aug 2017
- Study start19 Jul 2017
- Primary completion1 Sep 2018
- Study completion29 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer of the ProstateStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized blinded, shared decision-impact and health-economic assessment study. 1000 appropriately screened consecutive patients seen during planning for a prostate biopsy will be enrolled. 500 patients will be randomized (blinded) to have the ExoDx Prostate (IntelliScore) test (Cohort A) and 500 (Cohort B) will proceed with conventional standard of care. At time of enrollment, neither the patient nor the urologist will be made aware of whether the patient will have an ExoDx Prostate (IntelliScore) test as part of their work-up. Cohort A EPI test results will be sent to the urologist for assessment and ultimately shared with the patient.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exosome Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CareFirst BlueCross BlueShield, Chesapeake Urology Research Associates
- Responsible party
- Sponsor
- Investigators
- Roger Tun, Study director, Exosome Diagnostics, Inc.Ronald F Tutrone, MD, Principal investigator, Chesapeake Urology Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235687
- Sponsor's protocol ID
- ECT2017-002
- Status last verified
- May 2022
- First submitted
- 28 Jul 2017
- Last updated
- 6 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tutrone R, Donovan MJ, Torkler P, Tadigotla V, McLain T, Noerholm M, Skog J, McKiernan J. Clinical utility of the exosome based ExoDx Prostate(IntelliScore) EPI test in men presenting for initial Biopsy with a PSA 2-10 ng/mL. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):607-614. doi: 10.1038/s41391-020-0237-z. Epub 2020 May 7.
PubMed 32382078Tutrone R, Lowentritt B, Neuman B, Donovan MJ, Hallmark E, Cole TJ, Yao Y, Biesecker C, Kumar S, Verma V, Sant GR, Alter J, Skog J. ExoDx prostate test as a predictor of outcomes of high-grade prostate cancer - an interim analysis. Prostate Cancer Prostatic Dis. 2023 Sep;26(3):596-601. doi: 10.1038/s41391-023-00675-1. Epub 2023 May 16.
PubMed 37193776Kretschmer 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 6 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Blinded, Shared Decision Impact Trial of the ExoDx Prostate (IntelliScore), EPI Test, in Men Presenting for Initial Biopsy.
- ClinicalTrials.gov ID
- NCT03235687
- Acronym / sponsor ID
- ECT2017-002
- Conditions
- Cancer of the Prostate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Exosome Diagnostics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- CareFirst BlueCross BlueShield, Chesapeake Urology Research Associates
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 29 Sep 2023 (estimated)
- First posted
- 1 Aug 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.
The purpose of this research study is to investigate the utility of a validated urine test which predicts the likelihood of high grade prostate cancer on an initial prostate biopsy.
Detailed description
Primary Objective(s)
- Evaluate performance of the ExoDx Prostate(IntelliScore) (EPI) to reduce the number of initial prostate biopsies by greater than or equal to 15% for men with an elevated Prostate-Specific Antigen 2-10ng/mL presenting for a biopsy in consultation with their urologist.
- Compare performance of both the ExoDx Prostate(IntelliScore) 15.6 and 20 cut-points with respect to the biopsy decision process.
- Assess physician satisfaction with the ExoDx Prostate(IntelliScore) report including test result presentation, graphics and interpretation.
- Assess urologist / patient satisfaction for ease of understanding test results and role on biopsy decision process.
Secondary Objectives
- Determine the medical economic impact of the ExoDx Prostate(IntelliScore) test in the prostate biopsy decision process.
- Correlation of the ExoDx Prostate(IntelliScore) score with the actual biopsy result by utilizing the Receiver Operating Characteristic of the Area Under Curve for discriminating high-grade (greater than or equal to Gleason Score 7, International Society of Urological Pathology 2 and 3) from low-grade (Gleason Score 6, International Society of Urological Pathology 1) and benign disease on initial prostate needle biopsy.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a prospective, randomized blinded, shared decision-impact and health-economic assessment study. 1000 appropriately screened consecutive patients seen during planning for a prostate biopsy will be enrolled. 500 patients will be randomized (blinded) to have the ExoDx Prostate (IntelliScore) test (Cohort A) and 500 (Cohort B) will proceed with conventional standard of care. At time of enrollment, neither the patient nor the urologist will be made aware of whether the patient will have an ExoDx Prostate (IntelliScore) test as part of their work-up. Cohort A EPI test results will be sent to the urologist for assessment and ultimately shared with the patient.
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Diagnostic Test: ExoDx Prostate (IntelliScore)Patients randomized to Cohort A will receive ExoDx Prostate (IntelliScore) test results along with a post-ExoDx Prostate (IntelliScore) test result questionnaire to evaluate impact of test results in the biopsy decision process, utility, ease of understanding and work-flow implementation. |
| Cohort B | No intervention | –Patients randomized to Cohort B will proceed with conventional standard of care. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 50 years of age
- Clinical suspicion for prostate cancer
- Elevated Prostate-specific antigen between: 2.0 - 10 ng/ mL
- No clinical history of a prior negative biopsy
Key exclusion criteria (7 listed)
- History of prior prostate biopsy.
- Use of medications or hormones that are known to affect serum Prostate-specific antigen levels within 3-6 months of study enrollment.
- 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 (Benign Prostatic Hyperplasia) or lower urinary track symptoms within 6 months of study enrollment.
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: EPIExoDx Prostate (IntelliScore) is a non-invasive, urinary 3-gene expression validated test in which the results of the assay are adjunctive to the ordering physician's clinical judgment and work-up of the patient in the determination of whether a prostate needle biopsy is necessary. The ExoDx Prostate (IntelliScore) was clinically validated to discriminate patients with higher grade prostate cancer from those with more indolent lower grade cancer and benign disease. | Diagnostic test | Cohort A |
Primary outcome
Evaluate performance of the ExoDx Prostate(IntelliScore)
Time frame: 6 Months
Evaluate performance of the ExoDx Prostate(IntelliScore) to reduce the number of initial prostate biopsies by greater than or equal to 15% for men with an elevated prostate specific antigen between 2-10ng/mL presenting for a biopsy in consultation with their urologist.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2022.
- Results publication: PubMed 32382078Tutrone R, Donovan MJ, Torkler P, Tadigotla V, McLain T, Noerholm M, Skog J, McKiernan J. Clinical utility of the exosome based ExoDx Prostate(IntelliScore) EPI test in men presenting for initial Biopsy with a PSA 2-10 ng/mL. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):607-614. doi: 10.1038/s41391-020-0237-z. Epub 2020 May 7.
- Derived from this study: PubMed 37193776Tutrone R, Lowentritt B, Neuman B, Donovan MJ, Hallmark E, Cole TJ, Yao Y, Biesecker C, Kumar S, Verma V, Sant GR, Alter J, Skog J. ExoDx prostate test as a predictor of outcomes of high-grade prostate cancer - an interim analysis. Prostate Cancer Prostatic Dis. 2023 Sep;26(3):596-601. doi: 10.1038/s41391-023-00675-1. Epub 2023 May 16.
- 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: 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.
Roger Tun study director
Exosome Diagnostics, Inc.
Ronald F Tutrone, MD principal investigator
Chesapeake Urology Research Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExoDx Prostate (IntelliScore) in people with Cancer of the Prostate, run by Exosome Diagnostics, Inc. 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 4 inclusion and 7 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 6 May 2022. 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?
Evaluate performance of the ExoDx Prostate(IntelliScore) (time frame: 6 Months). 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 NCT03235687, which also lists 3 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 6 May 2022.