NCT03630926

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.

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Benign Prostatic Hypertrophy
• Bladder Stones
• Kidney Stones

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	NV-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.

Timeline

• Start date: 2018-10-16
• Primary completion: 2019-08-01
• Completion: 2019-12-01
• First posted: 2018-08-15
• Last updated: 2019-04-26

Locations

1 site across 1 country: United States