An observational study in Prostate Cancer Detection, sponsored by Sequenom, Inc.. Recruiting at 7 sites in United States. Open to male participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Sequenom, Inc. (part of Labcorp) · Observational
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.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 500 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Sequenom, Inc. is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
First submitted after Sequenom, Inc. became part of Labcorp.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 28, 2026. See what changed
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
7 Study blood sample will be collected prior to MRI (if conducted) and prior to the biopsy.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects with an elevated PSA (2-10) planning to undergo prostate biopsy
Diagnostic Test: Proclarix
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.
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.
Time frame: From enrollment to the collection of prostate biopsy results at 90 days
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.
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.
Compare other validated study endpoints to study test results.
Time frame: From enrollment to collection of biopsy results at 90 days
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Mar 2027, 11 months after the start.
Of 109 industry-sponsored observational studies under Prostatic Neoplasms, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 65. This study's planned 11 months is below that.
Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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