Benign Prostatic Hypertrophy, Bladder Stones, Kidney Stones, Prostate Cancer
Conditions
Keywords
NV-VPAC1 Prostate Cancer Urine Diagnostic test
Brief summary
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.
Interventions
DIAGNOSTIC_TESTNV-VPAC1 PCa Urine Diagnostic Test
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.
Sponsors
NuView Diagnostics
Intermountain Health Care, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 6 months | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Association between PSA levels and NV-VPAC1 test results. | 6 months |
Countries
United States
Outcome results
None listed