[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04788277":3,"trial-entities:NCT04788277":111,"trial-summary:NCT04788277":117},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":43,"secondary_outcomes":48,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":91,"locations":94,"central_contacts":104,"overall_officials":105,"references":109,"see_also_links":110},"NCT04788277","20G.196","Investigation Into Detection of Prostate Cancer Using Voided Urine (Prostate VPAC)","Investigation Into Detection of Prostate Cancer Using Voided Urine","ACTIVE_NOT_RECRUITING","2027-01","2026-06","2026-06-30","2020-02-26","Thomas Jefferson University","OTHER",false,"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 \u002F volunteers.","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.\n\nPatients 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:\n\n* Cohort 1 (PCa) Males 50-70 years of age N = 150\n\n  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\n* Cohort 2 (Normal) Males 50-70 years of age N = 125\n\n  * Normal control males\n  * Not known to have prostate cancer and have PSA \\\u003C\u002F=1.5 ng\u002Fml\n  * Excluded are patients with renal etiology of disease\n* Cohort 3 (Benign Prostatic Hyperplasia, BPH) Males 50-70 years of age N = 100\n\n  o Patients with a BPH diagnosis, but no prostate cancer, having PSA \\\u003C\u002F= 1.5 ng\u002Fml within the past year\n* Cohort 4 (Persistently Elevated, PE) Males 50-70 years of age N = 100\n\n  * Patients with a negative prostate biopsy resulted within the last 1 year from the day of consent\n  * Patients must have at least 2 PSA values greater than 2.5 ng\u002FmL, with the most recent value being resulted within the last year from the day of consent, unless other approved by the PI\n  * Exclusion Criteria for this cohort remains:\n  * Patients with cancers along the GU tract, not including penile or testicular cancers\n  * Patients taking finasteride or dutasteride\n  * 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.\n\nResults shall be recorded and then corroborated retrospectively to the patient's condition.\n\n* 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.\n* 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.",[19],"Prostate Carcinoma",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},810,"ACTUAL",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":39},"PROCEDURE","Biospecimen Collection","Undergo collection of urine samples",[33,34,35,36,37,38],"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)",[40,41,42],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",[44],{"measure":45,"description":46,"timeFrame":47},"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\u002For 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)",[49,52,55,58,61],{"measure":50,"description":51,"timeFrame":47},"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)",{"measure":53,"description":54,"timeFrame":47},"Fluorescence Intensity around Malignant Cells","Correlation of mean fluorescence intensity around malignant cells with disease aggressiveness",{"measure":56,"description":57,"timeFrame":47},"VPAC Protein Quantity in Shed Malignant Cells","VPAC protein amount in malignant urinary cells correleated with disease aggressiveness.",{"measure":59,"description":60,"timeFrame":47},"STEAP1 Receptor Density","Determined by receptor-specific immunohistochemistry; compared across GG1-5",{"measure":62,"description":63,"timeFrame":47},"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).","MALE","50 Years","79 Years",true,{"inclusion":69,"exclusion":89,"raw_text":90},[70,71,72,73,74,75,76,77,78,76,79,80,81,82,83,84,85,86,87,88],"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 \\\u003C or = 1.5 ng\u002Fml 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)","Previous history of PSA \\>1.5 ng\u002Fml are still eligible if they underwent surgery for the treatment of BPH and had a subsequent decrease in PSA below 1.5 ng\u002Fm","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\u002FdL 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.","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",[],"Individuals must meet all the following inclusion criteria in order to be eligible to participate in the study:\n\n* Provide signed and dated informed consent form (ICF)\n* Male\n* Patients must be 50-70 years of age (VPAC) or 50-75 (STEAP1)\n* Willing to comply with all study procedures VPAC Specific Aim 1 - Prostate Cancer, PCa (N = 150)\n* Known diagnosis of untreated prostate cancer, scheduled for robotic prostatectomy\n* No prior treatment (surgery, radiation, or medical therapy) Specific Aim 1.1 - Normal PSA (N = 125)\n* PSA \\\u003C or = 1.5 ng\u002Fml within the last year\n* No diagnosis or suspicion of cancer anywhere along the genitourinary tract\n* 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)\n* PSA \\\u003C or = 1.5 ng\u002Fml within the last year\n* Previous history of PSA \\>1.5 ng\u002Fml are still eligible if they underwent surgery for the treatment of BPH and had a subsequent decrease in PSA below 1.5 ng\u002Fm\n* Has a diagnosis of BPH, BOO, or LUTS Specific Aim 2 - Persistently Elevated PSA, PE (N = 100)\n* Patients with a negative prostate biopsy within the last 1 year from the day of consent\n* At least two elevated PSA values, defined as 2.5 ng\u002FdL or greater, with the most recent result being within the last 1 year from the day of consent, unless otherwise approved by the PI\n* HGPIN and ASAP are considered negative\n* 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.\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Subjects under the age of 50 or over the age of 70 (VPAC) or above 75 (STEAP1)\n* Individuals with any cancers along the genitourinary tract (does not include penile or testicular cancers)\n* Individuals taking finasteride or dutasteride, which decreases the PSA value\n* Individuals with gross hematuria suspicious of bladder cancer",[92,93],"ADULT","OLDER_ADULT",[95],{"facility":96,"city":97,"state":98,"zip":99,"country":100,"geoPoint":101},"Thomas Jefferson University Hospital","Philadelphia","Pennsylvania","19107","United States",{"lat":102,"lon":103},39.95238,-75.16362,[],[106],{"name":107,"affiliation":13,"role":108},"Madhukar Thakur, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":112,"biomarkers":114},[113,19],"Benign Prostatic Hyperplasia",[115,116],"Metalloreductase STEAP1","Vasoactive Intestinal Polypeptide Receptor 1",{"nct_id":4,"found":67,"summary":118,"prompt_version":128},{"design":119,"status":120,"heading":121,"summary":122,"follow_up":123,"word_count":124,"commitments":125,"compensation":126,"drugs_mentioned":127},"This is an observational study with a planned enrollment of 810 men. It is not testing a new treatment, but rather a new detection method.","completed","Investigating Prostate Cancer Detection Using Urine Samples","This observational study, called Prostate VPAC, is looking for men aged 50-79 to help researchers find a new way to detect prostate cancer. The study aims to see if an optical imaging method, which targets VPAC1 and STEAP1 receptors on prostate cancer cells, can successfully identify cancer cells shed in urine. You would provide a urine sample, and researchers will analyze it to see how well this new method works compared to your current prostate cancer status. The goal is to develop a less invasive way to detect prostate cancer. The study is currently recruiting participants.","The primary outcome, the sensitivity and specificity of the detection method, will be measured at one time urine collection, with analysis throughout the study period (approximately 2 years).",96,"You would provide a single urine sample (15-50 ml) at a urology clinic or community screening event. There are no other procedures or treatments involved.","Not stated in the trial record.",[],"v2"]