NCT04788277

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

Investigation Into Detection of Prostate Cancer Using Voided Urine

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 675 (estimated)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Male
• Age: 50 Years – 79 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is an observational study. No therapy is involved, and no treatment decisions are made as a part of this study. Patients will have biospecimen collected at either Urology clinics located at Jefferson Urology (Center City), Albert Einstein Medical Center, or SKCCC Mobile Prostate Cancer Screening community events. The biospecimens samples collected for this study will be used for research including conducting molecular analysis to identify biomarkers that are associated with prostate cancer prognosis. Patients presented to the urology clinic or community prostate cancer screening events and will be approached to sign informed consent form. Consenting patients shall provide 15-50 ml of voided urine in a sterile container. The patient collection population will consist of these specific cohorts: * Cohort 1 (PCa) Males 50-70 years of age N = 150 o Known to have prostate cancer (PCa) with any Gleason Score (Prognostic Grade Group, or PGG, Rating 1 to 5) without any treatment including surgery, radiation, or medication, who are scheduled for surgical excision with radical prostatectomy * Cohort 2 (Normal) Males 50-70 years of age N = 125 * Normal control males * Not known to have prostate cancer and have PSA \</=1.5 ng/ml * Excluded are patients with renal etiology of disease * Cohort 3 (Benign Prostatic Hyperplasia, BPH) Males 50-70 years of age N = 100 o Patients with a BPH diagnosis, but no prostate cancer, having PSA \</= 1.5 ng/ml within the past year * Cohort 4 (Persistently Elevated, PE) Males 50-70 years of age N = 100 * Patients with a negative prostate biopsy resulted within the last 1 year from the day of consent * Patients must have at least 2 PSA values greater than 2.5 ng/mL, with the most recent value being resulted within the last year from the day of consent, unless other approved by the PI * Exclusion Criteria for this cohort remains: * Patients with cancers along the GU tract, not including penile or testicular cancers * Patients taking finasteride or dutasteride * Patients providing a sample with microscopic or gross hematuria The urine samples will then be processed in the Dr. Thakur laboratory using the protocol established in the laboratory. Dr. Thakur and the lab personnel shall be unblinded to the donor condition and their group to which the sample belongs. Results shall be recorded and then corroborated retrospectively to the patient's condition. * Cohort 5 (STEAP1-Prostate Cancer GG1-GG5) Male participants with pathology-confirmed prostate cancer (Gleason Grade Groups 1-5). Urine samples are analyzed for six transmembrane epithelial antigens of prostate 1 (STEAP1) expression using fluorescent peptide imaging assay. STEAP1 fluorescence intensity and receptor density are correlated with tumor grade and disease aggressiveness. * Cohort 6 (STEAP1--Age-Matched Non-Malignant) Age-matched male participants without known prostate malignancy. Urine samples are analyzed for STEAP1 expression to establish baseline fluorescence intensity and assay specificity in non-cancerous controls.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of urine samples

Timeline

• Start date: 2020-02-26
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2021-03-09
• Last updated: 2026-03-13

Locations

1 site across 1 country: United States