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.
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.
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.