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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT04788277
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
50 Years - 79 Years
Healthy Volunteers
Accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of urine samples

Study Details

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.

Key Dates

Start date
Feb 26, 2020
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
675 participants (estimated)

Arms

  • Arm: Cohort 1 (PCa)
    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. Urine samples are analyzed for vasoactive intestinal polypeptide receptor 1 (VPAC1) expression using fluorescent peptide-based imaging assay. Data will be used to determine diagnostic accuracy, sensitivity, and specificity of VPAC1 assay and correlation with histopathologic findings.
  • Arm: Cohort 2 (Normal)
    * Normal control males * Not known to have prostate cancer and have PSA \</=1.5 ng/ml * Excluded are patients with renal etiology of disease Samples serve as healthy controls to establish a baseline VPAC1 fluorescence intensity and assay specificity in non-malignant populations.
  • Arm: Cohort 3 (Benign Prostatic Hyperplasia, BPH)
    Patients with a BPH diagnosis, but no prostate cancer, having PSA \</= 1.5 ng/ml within the past year. Urine samples are analyzed for VPAC1 receptor expression to evaluate assay discrimination between benign and malignant prostate conditions.
  • Arm: Cohort 4 (Persistently Elevated, PE)
    * 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 This cohort evaluates VPAC1 assay performance and potential false-positive signals in patients with elevated PSA but no confirmed malignancy.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

The sensitivity and specificity of the VPAC and STEAP1 assay diagnosis [ Time Frame: 1 time urine collection; analysis though study period (approximately 2 years) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Madhukar Thakur, MD
[email protected]
215-503-7874

Find similar trials in Philadelphia, PA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Thomas Jefferson University Hospital· Philadelphia, PA

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