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Investigating Prostate Cancer Detection Using Urine Samples

This observational study, called Prostate VPAC, is looking for men aged 50-79 to help researchers find a new way to detect prostate cancer. The study aims to see if an optical imaging method, which targets VPAC1 and STEAP1 receptors on prostate cancer cells, can successfully identify cancer cells shed in urine. You would provide a urine sample, and researchers will analyze it to see how well this new method works compared to your current prostate cancer status. The goal is to develop a less invasive way to detect prostate cancer. The study is currently recruiting participants.

Study design
This is an observational study with a planned enrollment of 810 men. It is not testing a new treatment, but rather a new detection method.
What's involved
You would provide a single urine sample (15-50 ml) at a urology clinic or community screening event. There are no other procedures or treatments involved.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, the sensitivity and specificity of the detection method, will be measured at one time urine collection, with analysis throughout the study period (approximately 2 years).

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NCT04788277

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

Active, Not Recruiting
Not specifiedAges 50–79Observational
Thomas Jefferson University
~810 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Biospecimen Collection

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The sensitivity and specificity of the VPAC and STEAP1 assay diagnosis
Measured over 1 time urine collection; analysis though study period (approximately 2 years)

Conditions

Prostate Carcinoma

Explore related trials

Benign Prostatic HyperplasiaProstate CarcinomaMetalloreductase STEAP1Vasoactive Intestinal Polypeptide Receptor 1

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Madhukar Thakur, MD · PRINCIPAL_INVESTIGATOR · Thomas Jefferson University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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

What this trial measures

  • The sensitivity and specificity of the VPAC and STEAP1 assay diagnosis1 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.