Pee test could spot prostate cancer early
NCT ID NCT04788277
First seen Jun 26, 2026 · Last updated Jul 01, 2026 · Updated 3 times
Summary
This study is testing a new way to detect prostate cancer by looking at cells in urine using a special imaging method. Researchers will collect urine samples from 675 men aged 50-75, including those with and without prostate cancer. The goal is to see if this simple test can accurately identify cancer and how aggressive it might be, potentially offering a non-invasive alternative to biopsies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Urine sample collection and optical imaging test
- What this could lead to
- If successful, this could lead to a simple, non-invasive urine test to detect prostate cancer, reducing the need for biopsies.
- What could go wrong
- This is an early-stage study focused on accuracy. The test may not be sensitive or specific enough to replace current methods, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
810 people
The number who actually took part.
- Started
-
Feb 2020
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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50 to 79 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
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Other studies related to the condition(s) this trial covers.
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