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

NCT04788277 | Recruiting

• 3 other identifiers: 20G.196JT 15161R01CA249921
• Study Type: observational
• Target: 675
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• The sensitivity and specificity of the VPAC and STEAP1 assay diagnosis

  The diagnostic properties of the assay will be assessed by estimating the sensitivity, specificity and positive and negative predictive values, along with their exact Clopper-Pearson 95% compatibility intervals. All study variables will be summarized and tabulated by prostate cancer status, BPH status, and by percent malignant cells (%M), fluorescence intensity, and VPAC and/or STEAP1 protein quantity. Continuous variables will be summarized in groups by means with standard deviations or, of skewed, by medians with first and third quartiles and with other continuous variables by correlation coefficients. Discrete variables will be summarized by frequency counts and percentages.

  1 time urine collection; analysis though study period (approximately 2 years)

Secondary Outcomes (5)

• Percent Malignant Cells in Urine

  1 time urine collection; analysis though study period (approximately 2 years)

• Fluorescence Intensity around Malignant Cells

  1 time urine collection; analysis though study period (approximately 2 years)

• VPAC Protein Quantity in Shed Malignant Cells

  1 time urine collection; analysis though study period (approximately 2 years)

• STEAP1 Receptor Density

  1 time urine collection; analysis though study period (approximately 2 years)

• STEAP1 Expression

  1 time urine collection; analysis though study period (approximately 2 years)

Study Arms (6)

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.

Procedure: Biospecimen Collection

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.

Procedure: Biospecimen Collection

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.

Procedure: Biospecimen Collection

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.

Procedure: Biospecimen Collection

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.

Procedure: Biospecimen Collection

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.

Procedure: Biospecimen Collection

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of urine samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Cohort 1 (PCa); Cohort 2 (Normal); Cohort 3 (Benign Prostatic Hyperplasia, BPH); Cohort 4 (Persistently Elevated, PE); Cohort 5 (STEAP1-Prostate Cancer GG1-GG5); Cohort 6 (STEAP1--Age-Matched Non-Malignant)

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Urine

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Madhukar Thakur, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madhukar Thakur, MD

CONTACT

215-503-7874; Madhukar.Thakur@jefferson.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 9, 2021
• Study Start: February 26, 2020
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (1)