Prostate CarcinomaNCT04788277
Investigation Into Detection of Prostate Cancer Using Voided Urine (Prostate VPAC)
An observational study of Prostate Carcinoma, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 79 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Biospecimen Collection
- Type of treatment
- Surgery or procedure
- How many people
- 810 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2020to Jan 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Investigation Into Detection of Prostate Cancer Using Voided Urine
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.
Read the 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
- 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
- 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
- Being tested
- Biospecimen Collection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of urine samples
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 time urine collection; analysis though study period (approximately 2 years)
Secondary outcomes (5)
Percent Malignant Cells in Urine
To establish if the malignant cells, as a percent of total cells shed in the urine, correlate with the aggressiveness of the disease. Proportion of malignant to total urinary cells (%M) and its correlation with Gleason Grade Group (GG1-5)
Measured: 1 time urine collection; analysis though study period (approximately 2 years)
Fluorescence Intensity around Malignant Cells
Correlation of mean fluorescence intensity around malignant cells with disease aggressiveness
Measured: 1 time urine collection; analysis though study period (approximately 2 years)
VPAC Protein Quantity in Shed Malignant Cells
VPAC protein amount in malignant urinary cells correleated with disease aggressiveness.
Measured: 1 time urine collection; analysis though study period (approximately 2 years)
STEAP1 Receptor Density
Determined by receptor-specific immunohistochemistry; compared across GG1-5
Measured: 1 time urine collection; analysis though study period (approximately 2 years)
STEAP1 Expression
To determine STEAPl expression as a function of PCa GG, 1-5 using quantitative RtPCR; analyzed statistically and compared with those of the control cohort and correlated to the PCa pathologic GG diagnosis (GG1-5).
Measured: 1 time urine collection; analysis though study period (approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start26 Feb 2020
- Primary completion1 Jun 2026
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 810 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Madhukar Thakur, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788277
- Sponsor's protocol ID
- 20G.196
- Other IDs
- JT 15161, R01CA249921
- Status last verified
- Jun 2026
- First submitted
- 4 Mar 2021
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Into Detection of Prostate Cancer Using Voided Urine
- ClinicalTrials.gov ID
- NCT04788277
- Acronym / sponsor ID
- 20G.196
- Conditions
- Prostate Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 810 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (PCa) | – | Procedure: Biospecimen CollectionKnown 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. |
| Cohort 2 (Normal) | – | Procedure: Biospecimen Collection* 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. |
| Cohort 3 (Benign Prostatic Hyperplasia, BPH) | – | Procedure: Biospecimen CollectionPatients 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. |
| Cohort 4 (Persistently Elevated, PE) | – | Procedure: Biospecimen Collection* 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. |
| Cohort 5 (STEAP1-Prostate Cancer GG1-GG5) | – | Procedure: Biospecimen CollectionMale 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) | – | Procedure: Biospecimen CollectionAge-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. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of urine samples | Procedure or surgery | 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) |
Primary outcome
The sensitivity and specificity of the VPAC and STEAP1 assay diagnosis
Time frame: 1 time urine collection; analysis though study period (approximately 2 years)
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.
5 secondary outcomes
Percent Malignant Cells in Urine
Time frame: 1 time urine collection; analysis though study period (approximately 2 years)
Fluorescence Intensity around Malignant Cells
Time frame: 1 time urine collection; analysis though study period (approximately 2 years)
VPAC Protein Quantity in Shed Malignant Cells
Time frame: 1 time urine collection; analysis though study period (approximately 2 years)
STEAP1 Receptor Density
Time frame: 1 time urine collection; analysis though study period (approximately 2 years)
STEAP1 Expression
Time frame: 1 time urine collection; analysis though study period (approximately 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhukar Thakur, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Carcinoma, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.