Prostate Cancer DetectionPRIMENCT07543757
Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix
An observational study of Prostate Cancer Detection, run by Sequenom, Inc. at 7 sites in United States.
Trial summary
The study is a prospective, multi-center, single cohort study involving up to 10 urological clinics in the US. After provision of informed consent, up to 20 mL of whole blood will be collected from each subject. The samples will be blinded and sent to Labcorp for evaluation using the Proclarix® assay. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer Detection
- What is being tested?
- Proclarix
- How many people
- 500 participants
- Where
- 7 sitesUnited States
- Study dates
- 3 Apr 2026to 31 Mar 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: Approximately 500 subjects will be enrolled in this study, of which approximately 400 subjects will have a tPSA value of 4-10 ng/mL and 100 subjects will have a tPSA of 2-<4 ng/mL.
Who may be able to join
- Subject is male ≥40 and ≤75 years of age at the time of enrollment;
- Subject provides a signed and dated informed consent;
- Subject has a SOC tPSA of 2-10 ng/mL inclusive within 90 days of the study blood draw;
- Subject is presenting to the clinic to discuss a potential prostate biopsy;
- Subject agrees to provide all diagnostic test results throughout the study; and
- Subject agrees to provide blood for Proclarix® and phi testing at the Screening Visit.
- 7 Study blood sample will be collected prior to MRI (if conducted) and prior to the biopsy.
Who cannot join
- Previous diagnosis of prostate cancer;
- Treatment with a medication classified as a 5α-reductase-inhibitor at any time in the 6 months prior to study blood collection;
- Acute or chronic urinary tract infection within 3 months of the study blood collection;
- Men with an indwelling catheter or intermittent self-catheterization within 30 days of the study blood collection;
- Digital Rectal Exam (DRE) or transurethral manipulation (e.g. cystoscopy, catheterization) the same day and prior to the study blood collection;
- Men who had an invasive urological procedure for benign prostate hyperplasia/obstruction (e.g. transurethral resection of the prostate (TURP), Holmium Laser Enucleation of the Prostate (HoLEP), Thulium laser enucleation of the prostate (ThuLEP), aquablation, prostatic artery embolization, Rezum, laser vaporization, etc.) or biopsy of the prostate within 6 months prior to the study blood collection;
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- Subject is not able to read or comprehend the informed consent form;
- Previous enrollment in this protocol with valid biopsy results; or
- Men who had an MRI of the prostate within 90 days prior to the study blood collection.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101
Christian Jones, 716-249-6700, cjones@circuitclinical.com
Tanya Atkins, 716-249-6700, tatkins@circuitclinical.com
- Recruiting
Chesapeake Urology Associates
Hanover, Maryland, 21076
Barbara Kyei, 410-760-9400, bkyei@chesuro.com
Kaiser Robertson, MD
- Recruiting
Idaho Urologic Institute
Meridian, Idaho, 83642
Brian Mihm, LPN, 208-639-4946, bmihm@idurology.com
Karrie Fox, BS, 208-639-4884, karried@idurology.com
- Recruiting
Crystal Run Healthcare
Middletown, New York, 10941
Dalea Frank, 716-249-6700, dfrank@circuitclinical.com
Lisa Crespi, 716-249-6700, lcrespi@circuitclinical.com
- Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Matt Parton, 843-839-1679, matthew.parton@startresearch.com
Jennifer Smith, 843-839-1679, jennifer.smith@startresearch.com
- Recruiting
Om Research
San Diego, California, 92123
Katie Golshan, 858-429-7050 ext. 2668, kgolshan@omclinicaltrials.com
Alanna Gavriushina, 858-429-7050 ext. 2668, alanna.gavriushina@uniohp.com
- Recruiting
Chesapeake Urology Associates
Towson, Maryland, 21204
Tawni Doliveira, 410-825-5454, tawni.doliveira@chesuro.com
Brian Neuman, MD
About this study
The study is a prospective, multi-center, single cohort study involving up to 10 urological clinics in the US. After provision of informed consent, up to 20 mL of whole blood will be collected from each subject. The samples will be blinded and sent to Labcorp for evaluation using the Proclarix® assay. If a prostate biopsy is performed, it will be performed according to standard clinical practice of the urologist (systematic, targeted, or combined biopsy with a transrectal or transperineal approach with or without prior magnetic resonance imaging (MRI)). A minimum of 10 cores is required if a systematic biopsy is performed. Histopathological examination of the biopsy specimen will be performed according to the established local practice. A csPCa is defined as ISUP Grade Group ≥2 detected on biopsy.
Read the detailed description
Prostate cancer remains a leading cause of cancer-related morbidity and mortality in men worldwide, with significant disparities in incidence and outcomes across different ethnic groups with black men being affected by prostate cancer earlier, more frequently and with more aggressive disease. Current risk stratification tools often lack the precision needed to effectively assess and predict prostate cancer risk in diverse populations.
Proclarix® is a blood-based test that addresses the problem of prostate cancer (PCa) overdiagnosis by indicating the risk of clinically significant disease. It is comprised of two novel biomarkers, thrombospondin 1 (THBS1) and cathepsin D (CTSD), and is combined with total prostate-specific antigen (tPSA), free PSA (fPSA) and age. A software algorithm returns a risk score that can be used as an aid in the identification of clinically significant PCa (csPCa), defined as International Society of Urological Pathology (ISUP) Grade Group ≥ 2. Proclarix® has been developed and validated on 955 men, in majority of Caucasian background with 90% sensitivity, 43% specificity, 95% negative predictive value (NPV) and 25% positive predictive value (PPV). The validation performance established on German and Austrian patients has been fully confirmed in other European populations: the United Kingdom, Spain, Denmark, Italy and Switzerland.
To be used broadly, confirmation of Proclarix® performance in patients from diverse ethnic backgrounds requires further investigation.
- Conditions
- Prostate Cancer Detection
- Being tested
- Proclarix
- Keywords
- prostate cancer, screening
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProclarixDiagnostic test
Proclarix® is a blood-based test that addresses the problem of prostate cancer (PCa) overdiagnosis by indicating the risk of clinically significant disease. It is comprised of two novel biomarkers, thrombospondin 1 (THBS1) and cathepsin D (CTSD), and is combined with total prostate-specific antigen (tPSA), free PSA (fPSA) and age.
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer suspected | Subjects with an elevated PSA (2-10) planning to undergo prostate biopsy Receives: Diagnostic Test: Proclarix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results.
Evaluate Proclarix®'s clinical performance, specifically NPV to predict the absence of csPCa on prostate biopsy.
Measured: From enrollment to the collection of prostate biopsy results at 90 days
Secondary outcomes (2)
Evaluate Proclarix's clinical ability to correlate with and add to the results of other diagnostic tests performed as standard of care (i.e., MRI, ultrasound, etc.)
Compare study test results to SOC screening and diagnostic tests.
Measured: From enrollment to collection of biopsy results at 90 days
Assess Proclarix®'s clinical performance compared with percent free PSA (%fPSA), the Prostate Health Index (phi), and a risk calculator as proposed by the American Urological Association (AUA) guidelines.
Compare other validated study endpoints to study test results.
Measured: From enrollment to collection of biopsy results at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start3 Apr 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer DetectionStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sequenom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Labcorp Corporation of America Holdings, Inc
- Responsible party
- Sponsor
- Investigators
- Neil Shore, MD, Principal investigator, Carolina Urologic Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543757
- Sponsor's protocol ID
- SQNM-PRO-401
- Acronym
- PRIME
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix
- ClinicalTrials.gov ID
- NCT07543757
- Acronym / sponsor ID
- PRIME / SQNM-PRO-401
- Conditions
- Prostate Cancer Detection
- Keywords
- prostate cancer, screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sequenom, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Labcorp Corporation of America Holdings, Inc
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Apr 2026 (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 a prospective, multi-center, single cohort study involving up to 10 urological clinics in the US. After provision of informed consent, up to 20 mL of whole blood will be collected from each subject. The samples will be blinded and sent to Labcorp for evaluation using the Proclarix® assay. If a prostate biopsy is performed, it will be performed according to standard clinical practice of the urologist (systematic, targeted, or combined biopsy with a transrectal or transperineal approach with or without prior magnetic resonance imaging (MRI)). A minimum of 10 cores is required if a systematic biopsy is performed. Histopathological examination of the biopsy specimen will be performed according to the established local practice. A csPCa is defined as ISUP Grade Group ≥2 detected on biopsy.
Detailed description
Prostate cancer remains a leading cause of cancer-related morbidity and mortality in men worldwide, with significant disparities in incidence and outcomes across different ethnic groups with black men being affected by prostate cancer earlier, more frequently and with more aggressive disease. Current risk stratification tools often lack the precision needed to effectively assess and predict prostate cancer risk in diverse populations.
Proclarix® is a blood-based test that addresses the problem of prostate cancer (PCa) overdiagnosis by indicating the risk of clinically significant disease. It is comprised of two novel biomarkers, thrombospondin 1 (THBS1) and cathepsin D (CTSD), and is combined with total prostate-specific antigen (tPSA), free PSA (fPSA) and age. A software algorithm returns a risk score that can be used as an aid in the identification of clinically significant PCa (csPCa), defined as International Society of Urological Pathology (ISUP) Grade Group ≥ 2. Proclarix® has been developed and validated on 955 men, in majority of Caucasian background with 90% sensitivity, 43% specificity, 95% negative predictive value (NPV) and 25% positive predictive value (PPV). The validation performance established on German and Austrian patients has been fully confirmed in other European populations: the United Kingdom, Spain, Denmark, Italy and Switzerland.
To be used broadly, confirmation of Proclarix® performance in patients from diverse ethnic backgrounds requires further investigation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer suspected | – | Diagnostic Test: ProclarixSubjects with an elevated PSA (2-10) planning to undergo prostate biopsy |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 500 subjects will be enrolled in this study, of which approximately 400 subjects will have a tPSA value of 4-10 ng/mL and 100 subjects will have a tPSA of 2-<4 ng/mL.
Key inclusion criteria (7 listed)
- Subject is male ≥40 and ≤75 years of age at the time of enrollment;
- Subject provides a signed and dated informed consent;
- Subject has a SOC tPSA of 2-10 ng/mL inclusive within 90 days of the study blood draw;
- Subject is presenting to the clinic to discuss a potential prostate biopsy;
- Subject agrees to provide all diagnostic test results throughout the study; and
Key exclusion criteria (9 listed)
- Previous diagnosis of prostate cancer;
- Treatment with a medication classified as a 5α-reductase-inhibitor at any time in the 6 months prior to study blood collection;
- Acute or chronic urinary tract infection within 3 months of the study blood collection;
- Men with an indwelling catheter or intermittent self-catheterization within 30 days of the study blood collection;
- Digital Rectal Exam (DRE) or transurethral manipulation (e.g. cystoscopy, catheterization) the same day and prior to the study blood collection;
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 |
|---|---|---|
| ProclarixProclarix® is a blood-based test that addresses the problem of prostate cancer (PCa) overdiagnosis by indicating the risk of clinically significant disease. It is comprised of two novel biomarkers, thrombospondin 1 (THBS1) and cathepsin D (CTSD), and is combined with total prostate-specific antigen (tPSA), free PSA (fPSA) and age. | Diagnostic test | Prostate cancer suspected |
Primary outcome
Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results.
Time frame: From enrollment to the collection of prostate biopsy results at 90 days
Evaluate Proclarix®'s clinical performance, specifically NPV to predict the absence of csPCa on prostate biopsy.
2 secondary outcomes
Evaluate Proclarix's clinical ability to correlate with and add to the results of other diagnostic tests performed as standard of care (i.e., MRI, ultrasound, etc.)
Time frame: From enrollment to collection of biopsy results at 90 days
Assess Proclarix®'s clinical performance compared with percent free PSA (%fPSA), the Prostate Health Index (phi), and a risk calculator as proposed by the American Urological Association (AUA) guidelines.
Time frame: From enrollment to collection of biopsy results at 90 days
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 28 Sep 2026.
- 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.
Neil Shore, MD principal investigator
Carolina Urologic Research Center
7 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 Detection, run by Sequenom, Inc. at 7 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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?
Contact Senior Clinical Trial Manager (858-202-2000, clinicalaffairsSD@labcorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results. (time frame: From enrollment to the collection of prostate biopsy results at 90 days). 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 28 Sep 2026.