Evaluation of the NV-VPAC1 Prostate Cancer (PCa) Urine Diagnostic Test in Subjects With Biopsy-confirmed Prostate Cancer, Benign Prostatic Hypertrophy, or Bladder/Kidney Stones.

Study Overview
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Brief Summary
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This is a double-blind, study to evaluate the performance of NV-VPAC1 PCa Urine Diagnostic Test in three distinct populations being treated at the Intermountain Urology Clinic. The first population (positive control) is comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy. The second population (negative control) is comprised of men with benign prostatic hypertrophy (BPH) who are scheduled for transurethral resection of the prostate (TURP). The third population (negative control) is comprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy.

Official Title
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Evaluation of the NV-VPAC1 Prostate Cancer (PCa) Urine Diagnostic Test in Subjects With Biopsy-confirmed Prostate Cancer, Benign Prostatic Hypertrophy, or Bladder/Kidney Stones

Conditions
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Prostate Cancer, Benign Prostatic Hypertrophy, Bladder Stones, Kidney Stones

Intervention / Treatment
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* Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic Test


Participation Criteria
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Eligibility Criteria
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Subjects with prostate cancer Inclusion Criteria: Males 18-80 years of age Biopsy-confirmed prostate cancer Scheduled within 2 weeks for prostatectomy Signed informed consent Exclusion Criteria: Presence or history of another cancer diagnosis, with the exception of certain skin cancers Currently treated with finasteride (Proscar®, Propecia®), dutasteride (Avodart®) or anti-androgen therapy (Lupron®) Participated in a clinical study with an investigational drug within 2 weeks of the screening visit. Subjects with benign prostatic hypertrophy Inclusion Criteria: Males 18-80 years of age Diagnosis of BPH made by clinical symptoms (e.g., enlarged prostate, dribbling urine stream, frequent and urgent urination) Scheduled within 2 weeks for TURP Signed informed consent Exclusion Criteria: Presence or history of any cancer diagnosis, with the exception of certain skin cancers Currently treated with finasteride (Proscar®, Propecia®) or dutasteride (Avodart®) Participated in a clinical study with an investigational drug within 2 weeks of the screening visit. Subjects with bladder/kidney stones Inclusion Criteria: Males or females 18-80 years of age Diagnosed with bladder/kidney stones Scheduled within 2 weeks for cystoscopy Signed informed consent Exclusion Criteria: Presence or history of any cancer diagnosis, with the exception of certain skin cancers Participated in a clinical study with an investigational drug within 2 weeks of the screening visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prostate Cancer (PCa)<br>Comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy. | Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic Test<br>* The NV-VPAC1 PCa Urine Diagnostic Test is intended for use by clinicians to detect the presence of prostate cancer cells shed in voided urine of men at risk for prostate cancer.<br>|
| Benign Prostatic Hypertrophy (BPH)<br>comprosed of men with benign prostatic hypertrophy (BPH) who are scheduled for transurethral resection of the prostate (TURP). | Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic Test<br>* The NV-VPAC1 PCa Urine Diagnostic Test is intended for use by clinicians to detect the presence of prostate cancer cells shed in voided urine of men at risk for prostate cancer.<br>|
| Bladder/kidney stone<br>Comprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy. | Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic Test<br>* The NV-VPAC1 PCa Urine Diagnostic Test is intended for use by clinicians to detect the presence of prostate cancer cells shed in voided urine of men at risk for prostate cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of association of the presence of orange fluorescent positive cells shed in voided urine and lack of association of orange fluorescent positive cells in men diagnosed with BPH or in individuals with bladder/kidney stones | Degree of association of the presence of orange fluorescent positive cells shed in voided urine of men with biopsy-proven PCa and lack of association of orange fluorescent positive cells in men diagnosed with BPH or in individuals with bladder/kidney stones | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between PSA levels and NV-VPAC1 test results. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NV-VPAC1 Prostate Cancer Urine Diagnostic test