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. (VPAC)

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

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer; Kidney Stones; Benign Prostatic Hypertrophy; Bladder Stones
• Intervention / Treatment: Diagnostic test: NV-VPAC1 PCa Urine Diagnostic Test

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with biopsy-confirmed prostate cancer, patients with BPH, and patients with bladder/kidney stones

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prostate Cancer (PCa); Comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy.	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.
Benign Prostatic Hypertrophy (BPH); 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; 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.
Bladder/kidney stone; Comprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy.	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.

What is the study measuring?

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	Time Frame
Association between PSA levels and NV-VPAC1 test results.	6 months

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: NuView Diagnostics
• Investigators: Principal Investigator: Jay Bishoff, MD, Intermountain Health Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 10, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): April 26, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: NV-VPAC1 Prostate Cancer Urine Diagnostic test
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Urinary Bladder Diseases; Genital Neoplasms, Male; Prostatic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Prostatic Neoplasms; Prostatic Hyperplasia; Hypertrophy; Calculi; Kidney Calculi; Nephrolithiasis; Urinary Bladder Calculi
• Other Study ID Numbers: VPAC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No