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.

Intermountain Health Care, Inc.45 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Cancer Benign Prostatic Hypertrophy Bladder Stones Kidney Stones

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 6 months

Secondary Outcomes

Association between PSA levels and NV-VPAC1 test results.