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Pee test could spot prostate cancer early

NCT ID NCT04788277

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

50 to 79 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.