Investigation Into Detection of Prostate Cancer Using Voided Urine (Prostate VPAC)

Investigation Into Detection of Prostate Cancer Using Voided Urine

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Carcinoma
• Intervention / Treatment: Procedure: Biospecimen Collection

Detailed Description

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

• 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

  o Patients with a BPH diagnosis, but no prostate cancer, having PSA </= 1.5 ng/ml within the past year

• Cohort 4 (Persistently Elevated, PE) Males 50-70 years of age N = 100

  • 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
  • Exclusion Criteria for this cohort remains:
  • Patients with cancers along the GU tract, not including penile or testicular cancers
  • Patients taking finasteride or dutasteride
  • Patients providing a sample with microscopic or gross hematuria The urine samples will then be processed in the Dr. Thakur laboratory using the protocol established in the laboratory. Dr. Thakur and the lab personnel shall be unblinded to the donor condition and their group to which the sample belongs.

Results shall be recorded and then corroborated retrospectively to the patient's condition.

• 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.
• 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.

• Study Type: Observational
• Enrollment (Estimated): 675

Contacts and Locations

• Study Contact: Name: Madhukar Thakur, MD; Phone Number: 215-503-7874; Email: Madhukar.Thakur@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University Hospital
      • Contact: Madhukar Thakur, MD; Phone Number: 215-503-7874; Email: Madhukar.Thakur@jefferson.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Male participants aged 50-79 years providing urine samples for VPAC1 and/or STEAP1 biomarker testing. Participants are grouped based on PSA level, prostate cancer status, or benign prostatic conditions.

Description

Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study:

• Provide signed and dated informed consent form (ICF)
• Male
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Biospecimen Collection; Undergo collection of urine samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection
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.	Procedure: Biospecimen Collection; Undergo collection of urine samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection
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.	Procedure: Biospecimen Collection; Undergo collection of urine samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection
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.	Procedure: Biospecimen Collection; Undergo collection of urine samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection
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.	Procedure: Biospecimen Collection; Undergo collection of urine samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection
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.	Procedure: Biospecimen Collection; Undergo collection of urine samples; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The sensitivity and specificity of the VPAC and STEAP1 assay diagnosis	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.	1 time urine collection; analysis though study period (approximately 2 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Malignant Cells in Urine	To establish if the malignant cells, as a percent of total cells shed in the urine, correlate with the aggressiveness of the disease. Proportion of malignant to total urinary cells (%M) and its correlation with Gleason Grade Group (GG1-5)	1 time urine collection; analysis though study period (approximately 2 years)
Fluorescence Intensity around Malignant Cells	Correlation of mean fluorescence intensity around malignant cells with disease aggressiveness	1 time urine collection; analysis though study period (approximately 2 years)
VPAC Protein Quantity in Shed Malignant Cells	VPAC protein amount in malignant urinary cells correleated with disease aggressiveness.	1 time urine collection; analysis though study period (approximately 2 years)
STEAP1 Receptor Density	Determined by receptor-specific immunohistochemistry; compared across GG1-5	1 time urine collection; analysis though study period (approximately 2 years)
STEAP1 Expression	To determine STEAPl expression as a function of PCa GG, 1-5 using quantitative RtPCR; analyzed statistically and compared with those of the control cohort and correlated to the PCa pathologic GG diagnosis (GG1-5).	1 time urine collection; analysis though study period (approximately 2 years)

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Madhukar Thakur, MD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling
• Other Study ID Numbers: 20G.196; JT 15161 (Other Identifier: JeffTrial Number); R01CA249921 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No