Investigation Into Detection of Prostate Cancer Using Voided Urine
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 810
- 试验地点
- 2
- 主要终点
- The sensitivity and specificity of the VPAC and STEAP1 assay diagnosis
研究概览
简要总结
The goal of this project is to detect prostate cancer cells, shed in voided urine, using the optical imaging method developed in our laboratory, which targets VPAC1 and STEAP1 receptors expressed on prostate cancer cells and validates the results with prevailing condition of the patients / volunteers.
详细描述
This is an observational study. No therapy is involved, and no treatment decisions are made as a part of this study. Patients will have biospecimen collected at either Urology clinics located at Jefferson Urology (Center City), Albert Einstein Medical Center, or SKCCC Mobile Prostate Cancer Screening community events. The biospecimens samples collected for this study will be used for research including conducting molecular analysis to identify biomarkers that are associated with prostate cancer prognosis.
Patients presented to the urology clinic or community prostate cancer screening events and will be approached to sign informed consent form. Consenting patients shall provide 15-50 ml of voided urine in a sterile container. The patient collection population will consist of these specific cohorts:
- Cohort 1 (PCa) Males 50-70 years of age N = 150
o Known to have prostate cancer (PCa) with any Gleason Score (Prognostic Grade Group, or PGG, Rating 1 to 5) without any treatment including surgery, radiation, or medication, who are scheduled for surgical excision with radical prostatectomy
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Cohort 2 (Normal) Males 50-70 years of age N = 125
-
Normal control males
-
Not known to have prostate cancer and have PSA </=1.5 ng/ml
-
Excluded are patients with renal etiology of disease
-
Cohort 3 (Benign Prostatic Hyperplasia, BPH) Males 50-70 years of age N = 100
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •in order to be eligible to participate in the study:
- •Provide signed and dated informed consent form (ICF)
- •Patients must be 50-70 years of age (VPAC) or 50-75 (STEAP1)
- •Willing to comply with all study procedures VPAC Specific Aim 1 - Prostate Cancer, PCa (N = 150)
- •Known diagnosis of untreated prostate cancer, scheduled for robotic prostatectomy
- •No prior treatment (surgery, radiation, or medical therapy) Specific Aim 1.1 - Normal PSA (N = 125)
- •PSA < or = 1.5 ng/ml within the last year
- •No diagnosis or suspicion of cancer anywhere along the genitourinary tract
- •No history of BPH Prostate VPAC Version 8.0 Protocol 20G.196 20 June 2025 Based on SKCC Interventional Protocol Template v.20170209 page 20 of 31 Specific Aim 1.2 - Benign Prostatic Hyperplasia, BPH (N = 100)
- •PSA < or = 1.5 ng/ml within the last year
- •Previous history of PSA >1.5 ng/ml are still eligible if they underwent surgery for the treatment of BPH and had a subsequent decrease in PSA below 1.5 ng/m
- •Has a diagnosis of BPH, BOO, or LUTS Specific Aim 2 - Persistently Elevated PSA, PE (N = 100)
- •Patients with a negative prostate biopsy within the last 1 year from the day of consent
- •At least two elevated PSA values, defined as 2.5 ng/dL or greater, with the most recent result being within the last 1 year from the day of consent, unless otherwise approved by the PI
- •HGPIN and ASAP are considered negative
- •Previous biopsy results, if a repeat prostate biopsy patient, do not need to be available, there is also no preferred timeframe of previous biopsy (can be >1 year at time of consent) STEAP1 Specific Aim 1: To determine STEAPl receptor density as a function of PCa GGl to 5 using receptors specific immunohistochemistry Specific Aim 2: To determine STEAPl expression as a function of PCa GG, 1-5 using quantitative RtPCR.
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Subjects under the age of 50 or over the age of 70 (VPAC) or above 75 (STEAP1)
- •Individuals with any cancers along the genitourinary tract (does not include penile or testicular cancers)
- •Individuals taking finasteride or dutasteride, which decreases the PSA value
- •Individuals with gross hematuria suspicious of bladder cancer
排除标准
- •Patients under the age of 50
研究组 & 干预措施
Cohort 1 (PCa)
Known to have prostate cancer (PCa) with any Gleason Score (Prognostic Grade Group, or PGG, Rating 1 to 5) without any treatment including surgery, radiation, or medication, who are scheduled for surgical excision with radical prostatectomy. Urine samples are analyzed for vasoactive intestinal polypeptide receptor 1 (VPAC1) expression using fluorescent peptide-based imaging assay. Data will be used to determine diagnostic accuracy, sensitivity, and specificity of VPAC1 assay and correlation with histopathologic findings.
干预措施: Biospecimen Collection (Procedure)
Cohort 2 (Normal)
- Normal control males
- Not known to have prostate cancer and have PSA </=1.5 ng/ml
- Excluded are patients with renal etiology of disease Samples serve as healthy controls to establish a baseline VPAC1 fluorescence intensity and assay specificity in non-malignant populations.
干预措施: Biospecimen Collection (Procedure)
Cohort 3 (Benign Prostatic Hyperplasia, BPH)
Patients with a BPH diagnosis, but no prostate cancer, having PSA </= 1.5 ng/ml within the past year. Urine samples are analyzed for VPAC1 receptor expression to evaluate assay discrimination between benign and malignant prostate conditions.
干预措施: Biospecimen Collection (Procedure)
Cohort 4 (Persistently Elevated, PE)
- Patients with a negative prostate biopsy resulted within the last 1 year from the day of consent
- Patients must have at least 2 PSA values greater than 2.5 ng/mL, with the most recent value being resulted within the last year from the day of consent, unless other approved by the PI This cohort evaluates VPAC1 assay performance and potential false-positive signals in patients with elevated PSA but no confirmed malignancy.
干预措施: Biospecimen Collection (Procedure)
Cohort 5 (STEAP1-Prostate Cancer GG1-GG5)
Male participants with pathology-confirmed prostate cancer (Gleason Grade Groups 1-5). Urine samples are analyzed for six transmembrane epithelial antigens of prostate 1 (STEAP1) expression using fluorescent peptide imaging assay. STEAP1 fluorescence intensity and receptor density are correlated with tumor grade and disease aggressiveness.
干预措施: Biospecimen Collection (Procedure)
Cohort 6 (STEAP1--Age-Matched Non-Malignant)
Age-matched male participants without known prostate malignancy. Urine samples are analyzed for STEAP1 expression to establish baseline fluorescence intensity and assay specificity in non-cancerous controls.
干预措施: Biospecimen Collection (Procedure)
结局指标
主要结局
The sensitivity and specificity of the VPAC and STEAP1 assay diagnosis
时间窗: 1 time urine collection; analysis though study period (approximately 2 years)
The diagnostic properties of the assay will be assessed by estimating the sensitivity, specificity and positive and negative predictive values, along with their exact Clopper-Pearson 95% compatibility intervals. All study variables will be summarized and tabulated by prostate cancer status, BPH status, and by percent malignant cells (%M), fluorescence intensity, and VPAC and/or STEAP1 protein quantity. Continuous variables will be summarized in groups by means with standard deviations or, of skewed, by medians with first and third quartiles and with other continuous variables by correlation coefficients. Discrete variables will be summarized by frequency counts and percentages.
次要结局
- Percent Malignant Cells in Urine(1 time urine collection; analysis though study period (approximately 2 years))
- Fluorescence Intensity around Malignant Cells(1 time urine collection; analysis though study period (approximately 2 years))
- VPAC Protein Quantity in Shed Malignant Cells(1 time urine collection; analysis though study period (approximately 2 years))
- STEAP1 Receptor Density(1 time urine collection; analysis though study period (approximately 2 years))
- STEAP1 Expression(1 time urine collection; analysis though study period (approximately 2 years))