Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 7
- 主要终点
- Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Prostate cancer suspected
Subjects with an elevated PSA (2-10) planning to undergo prostate biopsy
干预措施: Proclarix (Diagnostic Test)
结局指标
主要结局
Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results.
时间窗: 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.
次要结局
- 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)