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.

NCT03630926 | Unknown

• 1 other identifier: VPAC
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

NV-VPAC1 Prostate Cancer Urine Diagnostic test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Association between PSA levels and NV-VPAC1 test results.

  6 months

Study Arms (3)

Prostate Cancer (PCa)

Comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy.

Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic Test

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

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

Interventions

NV-VPAC1 PCa Urine Diagnostic Test 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); Bladder/kidney stone; Prostate Cancer (PCa)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Males 18-80 years of age
• Biopsy-confirmed prostate cancer
• Scheduled within 2 weeks for prostatectomy
• Signed informed consent

You may not qualify if:

• 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
• 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
• 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
• Males or females 18-80 years of age
• Diagnosed with bladder/kidney stones
• Scheduled within 2 weeks for cystoscopy

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• NuView Diagnostics: collaborator

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine specimens

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Hyperplasia; Urinary Bladder Calculi; Kidney Calculi

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Calculi; Urolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Nephrolithiasis; Kidney Diseases

Study Officials

• Jay Bishoff, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Intermountain Urological Institute

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 15, 2018
• Study Start: October 16, 2018
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 26, 2019

Record last verified: 2019-04

Locations

US (1)