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.

Prostate Cancer Clinical Trial

— VPAC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03630926
• Other study ID #: VPAC
• Status: Active, not recruiting
• Start date: October 16, 2018
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: December 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hypertrophy
• Bladder Stones
• Calculi
• Hypertrophy
• Kidney Calculi
• Kidney Stones
• Nephrolithiasis
• Prostate Cancer
• Prostatic Hyperplasia
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	NuView Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Association between PSA levels and NV-VPAC1 test results.		6 months