Prostate CancerAPCaRI-05NCT03957252
Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer
An observational study of Prostate Cancer and Prostate Cancer Screening, run by Nanostics at 3 sites in 2 countries.
Trial summary
This ambispective observational cohort study will evaluate the clinical performance of the ClarityDX Prostate blood test in men with a prostate-specific antigen (PSA) level of 3 ng/mL or higher who are undergoing prostate biopsy due to suspicion of prostate cancer. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer Screening, Performance Assessment of Novel Test
- How many people
- 2,800 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 6 Jun 2019to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: This prospective training and validation cohort study will consist of up to 2,800 consenting men from Alberta in addition to up to 5,000 men from external institutions, between ages 40-75 (inclusive) years old, without prior diagnosis of prostate cancer, who have been selected to undergo a prostate biopsy to rule out prostate cancer. Only patients with Total PSA >/= 3 ng/mL will be selected to have the ClarityDX Prostate test performed as a reflex test.
Who may be able to join
- Males between 40-75 (inclusive) years of age;
- With and without family history of prostate cancer;
- No prior prostate cancer diagnosis and who are referred to have a prostate biopsy;
- Total PSA results >/= 3ng/mL collected within 6m of enrollment;
- Willing to permit provincial agencies (e.g. Alberta Health Services, Alberta Health, Netcare, Service Alberta or other based on recruitment jurisdiction) to disclose health-related information to study;
- Undergoing a diagnostic prostate biopsy; and
- Provided informed consent to participate in the study.
Who cannot join
- Unwilling to participate in the study;
- Unavailable for biopsy procedure in recruitment areas;
- Not undergoing a prostate biopsy;
- Prior diagnosis of cancer excluding non-melanoma skin cancer; and/or
- Under the age of 40 years of age or over the age of 75 years of age.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Canada2 sites
Prostate Cancer Centre
Calgary, Alberta, T2V 1P9
Kipnes Urology Centre
Edmonton, Alberta, T6G 1Z1
About this study
Official title: Clinical Validation of ClarityDX Prostate as a Reflex Test to Prostate Specific Antigen (PSA) to Refine the Prediction of Clinically-significant Prostate Cancer
This ambispective observational cohort study will evaluate the clinical performance of the ClarityDX Prostate blood test in men with a prostate-specific antigen (PSA) level of 3 ng/mL or higher who are undergoing prostate biopsy due to suspicion of prostate cancer. The study will compare ClarityDX Prostate test results with biopsy outcomes to determine the test's ability to identify the presence of clinically significant prostate cancer.
Read the detailed description
The main objective of this study is to validate ClarityDX Prostate as a reflex test to PSA to refine the prediction of clinically-significant prostate cancer in a prospective cohort of men to be recruited in North America when they are scheduled for a biopsy as a result of on an elevated PSA or other suspicion of prostate cancer and in retrospective databases from selected sites in the United States of America and the world.
The training and validation analysis sets will consist of up to 2,800 consenting men from Alberta in addition to up to 5,000 men from external institutions, between ages 40-75 (inclusive) years old, without prior diagnosis of prostate cancer, who have been selected to undergo a prostate biopsy to rule out prostate cancer.
- Keywords
- ClarityDX Prostate, Diagnosis, Reflex Test
- Medical subject headings
- Prostatic Neoplasms, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Clinical Performance: prediction of clinically significant prostate cancer at biopsy
Training Phase: Processed clinical features of each patient will be analyzed using machine learning to predict clinically significant prostate cancer, with the output being the ClarityDX Prostate Risk Score.
Validation Phase: The models created during the Training Phase will be locked down and then used to determine the probability of approximately 1,400 patients in the investigational Validation Phase having clinically significant prostate cancer.
Measured: 3 years
Active Surveillance: prediction of Gleason Grade Group on confirmatory/follow-up biopsies for participants on Active Surveillance
Measured: 4 years
MRI: prediction of PI-RADS pre-diagnostic biopsy
Measured: 4 years
Secondary outcomes (3)
Health economics
Perform health economics and cost-benefit analyss of the test
Measured: 3 years
Medication and co-morbidities
Effect of selected medications and co-morbidities on the predictive value of the test
Measured: Baseline
Analytical validity of the ClarityDX Prostate test
Method assessment and analytical validity of the ClarityDX Prostate test.
Measured: 1 year post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start6 Jun 2019
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
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 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
- Other
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alberta Prostate Cancer Research Initiative, APCaRI, Prostate Cencer Centre, Calgary, Alberta Cancer Foundation, Alberta Innovates Health Solutions, Motorcycle Ride for Dad, University Hospital Foundation - The Kaye Fund Competition, Alberta Precision Laboratories, Kipnes Urology Centre
- Responsible party
- Sponsor
- Investigators
- Adrian S Fairey, MD, MSc, Principal investigator, Kipnes Urology Centre, University of AlbertaMatthew E Hyndman, MD, PhD, Principal investigator, Southern Alberta Institute of Urology, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957252
- Sponsor's protocol ID
- APCaRI-05
- Acronym
- APCaRI-05
- Status last verified
- Jul 2026
- First submitted
- 17 May 2019
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paproski RJ, Kinnaird A, Hyndman ME, Fairey A, Marks L, Pavlovich CP, Fletcher SA, Zachoval R, Adamcova V, Stejskal J, Aprikian A, Wallis CJD, Pink D, Vasquez C, Beatty PH, Lewis JD. Predicting clinically significant prostate cancer with or without digital rectal exam and MRI data using ClarityDX Prostate models. NPJ Digit Med. 2026 Apr 17;9(1):467. doi: 10.1038/s41746-026-02642-1.
PubMed 41998222Hyndman ME, Paproski RJ, Kinnaird A, Fairey A, Marks L, Pavlovich CP, Fletcher SA, Zachoval R, Adamcova V, Stejskal J, Aprikian A, Wallis CJD, Pink D, Vasquez C, Beatty PH, Lewis JD. Development of an effective predictive screening tool for prostate cancer using the ClarityDX machine learning platform. NPJ Digit Med. 2024 Jun 20;7(1):163. doi: 10.1038/s41746-024-01167-9.
PubMed 38902526
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of ClarityDX Prostate as a Reflex Test to Prostate Specific Antigen (PSA) to Refine the Prediction of Clinically-significant Prostate Cancer
- ClinicalTrials.gov ID
- NCT03957252
- Acronym / sponsor ID
- APCaRI-05 / APCaRI-05
- Keywords
- ClarityDX Prostate, Diagnosis, Reflex Test
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- NanosticsIndustry (pharma, biotech, devices)
- Collaborators
- Alberta Prostate Cancer Research Initiative, APCaRI, Prostate Cencer Centre, Calgary, Alberta Cancer Foundation, Alberta Innovates Health Solutions, Motorcycle Ride for Dad, University Hospital Foundation - The Kaye Fund Competition, Alberta Precision Laboratories, Kipnes Urology Centre
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 May 2019 (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.
This ambispective observational cohort study will evaluate the clinical performance of the ClarityDX Prostate blood test in men with a prostate-specific antigen (PSA) level of 3 ng/mL or higher who are undergoing prostate biopsy due to suspicion of prostate cancer. The study will compare ClarityDX Prostate test results with biopsy outcomes to determine the test's ability to identify the presence of clinically significant prostate cancer.
Detailed description
The main objective of this study is to validate ClarityDX Prostate as a reflex test to PSA to refine the prediction of clinically-significant prostate cancer in a prospective cohort of men to be recruited in North America when they are scheduled for a biopsy as a result of on an elevated PSA or other suspicion of prostate cancer and in retrospective databases from selected sites in the United States of America and the world.
The training and validation analysis sets will consist of up to 2,800 consenting men from Alberta in addition to up to 5,000 men from external institutions, between ages 40-75 (inclusive) years old, without prior diagnosis of prostate cancer, who have been selected to undergo a prostate biopsy to rule out prostate cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective training and validation cohort study will consist of up to 2,800 consenting men from Alberta in addition to up to 5,000 men from external institutions, between ages 40-75 (inclusive) years old, without prior diagnosis of prostate cancer, who have been selected to undergo a prostate biopsy to rule out prostate cancer. Only patients with Total PSA >/= 3 ng/mL will be selected to have the ClarityDX Prostate test performed as a reflex test.
Key inclusion criteria (7 listed)
- Males between 40-75 (inclusive) years of age;
- With and without family history of prostate cancer;
- No prior prostate cancer diagnosis and who are referred to have a prostate biopsy;
- Total PSA results >/= 3ng/mL collected within 6m of enrollment;
- Willing to permit provincial agencies (e.g. Alberta Health Services, Alberta Health, Netcare, Service Alberta or other based on recruitment jurisdiction) to disclose health-related information to study;
Key exclusion criteria (5 listed)
- Unwilling to participate in the study;
- Unavailable for biopsy procedure in recruitment areas;
- Not undergoing a prostate biopsy;
- Prior diagnosis of cancer excluding non-melanoma skin cancer; and/or
- Under the age of 40 years of age or over the age of 75 years of age.
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
Diagnostic Clinical Performance: prediction of clinically significant prostate cancer at biopsy
Time frame: 3 years
Training Phase: Processed clinical features of each patient will be analyzed using machine learning to predict clinically significant prostate cancer, with the output being the ClarityDX Prostate Risk Score. Validation Phase: The models created during the Training Phase will be locked down and then used to determine the probability of approximately 1,400 patients in the investigational Validation Phase having clinically significant prostate cancer.
Active Surveillance: prediction of Gleason Grade Group on confirmatory/follow-up biopsies for participants on Active Surveillance
Time frame: 4 years
MRI: prediction of PI-RADS pre-diagnostic biopsy
Time frame: 4 years
3 secondary outcomes
Health economics
Time frame: 3 years
Medication and co-morbidities
Time frame: Baseline
Analytical validity of the ClarityDX Prostate test
Time frame: 1 year post enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Results publication: PubMed 41998222Paproski RJ, Kinnaird A, Hyndman ME, Fairey A, Marks L, Pavlovich CP, Fletcher SA, Zachoval R, Adamcova V, Stejskal J, Aprikian A, Wallis CJD, Pink D, Vasquez C, Beatty PH, Lewis JD. Predicting clinically significant prostate cancer with or without digital rectal exam and MRI data using ClarityDX Prostate models. NPJ Digit Med. 2026 Apr 17;9(1):467. doi: 10.1038/s41746-026-02642-1.
- Results publication: PubMed 38902526Hyndman ME, Paproski RJ, Kinnaird A, Fairey A, Marks L, Pavlovich CP, Fletcher SA, Zachoval R, Adamcova V, Stejskal J, Aprikian A, Wallis CJD, Pink D, Vasquez C, Beatty PH, Lewis JD. Development of an effective predictive screening tool for prostate cancer using the ClarityDX machine learning platform. NPJ Digit Med. 2024 Jun 20;7(1):163. doi: 10.1038/s41746-024-01167-9.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Adrian S Fairey, MD, MSc principal investigator
Kipnes Urology Centre, University of Alberta
Matthew E Hyndman, MD, PhD principal investigator
Southern Alberta Institute of Urology, University of Calgary
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 Prostate Cancer and Prostate Cancer Screening, run by Nanostics 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 7 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. 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 Canada, 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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnostic Clinical Performance: prediction of clinically significant prostate cancer at biopsy (time frame: 3 years). The study lists 3 primary outcomes in all. 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 NCT03957252, 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 24 Jul 2026.