Detecting prostate cancer using urine samples
Investigation Into Detection of Prostate Cancer Using Voided Urine
This study is testing a new way to find prostate cancer by looking for cancer cells in urine samples from men with high PSA levels or diagnosed with prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 675 (estimated) |
| Ages | 50 Years to 79 Years |
| Sex | Male |
| Sponsor | Thomas Jefferson University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04788277 on ClinicalTrials.gov |
What this trial studies
This observational study collects urine samples from male patients at a urology clinic to identify prostate cancer cells using an optical imaging method that targets specific biomarkers on these cells. The primary objective is to evaluate the diagnostic accuracy of this method in patients with elevated prostate-specific antigen (PSA) levels and those diagnosed with prostate cancer. Secondary objectives include assessing the percentage of malignant cells in urine and their fluorescence intensity, as well as correlating VPAC protein levels with disease aggressiveness. The study aims to develop a simple diagnostic test for prostate cancer management.
Who should consider this trial
Good fit: Ideal candidates include males aged 50-70 with elevated PSA levels, those diagnosed with prostate cancer, or individuals with normal PSA levels and no history of prostate issues.
Not a fit: Patients with a documented history of prostate cancer who have already undergone treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a non-invasive diagnostic test for prostate cancer, improving early detection and management.
How similar studies have performed: While similar approaches have been explored, this specific optical imaging method targeting VPAC1 receptors is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Madhukar Thakur, MD — Thomas Jefferson University
- Study coordinator: Madhukar Thakur, MD
- Email: Madhukar.Thakur@jefferson.edu
- Phone: 215-503-7874
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.