Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Sequenom, Inc.
- Enrollment
- 500
- Locations
- 7
- Primary Endpoint
- Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results.
Study Overview
Brief 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. 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
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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;
- •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.
Arms & Interventions
Prostate cancer suspected
Subjects with an elevated PSA (2-10) planning to undergo prostate biopsy
Intervention: Proclarix (Diagnostic Test)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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.(From enrollment to collection of 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.)(From enrollment to collection of biopsy results at 90 days)