RecruitingNCT04788277

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

Investigation Into Detection of Prostate Cancer Using Voided Urine

Sponsor

Thomas Jefferson University

Enrollment

675 participants

Start Date

Feb 26, 2020

Study Type

OBSERVATIONAL

Conditions

Prostate Carcinoma

Summary

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.

Eligibility

Sex: MALEMin Age: 50 YearsMax Age: 79 Years

Inclusion Criteria21

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