Clinical trial NCT03630926: 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.
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Benign Prostatic Hypertrophy
Bladder Stones
Kidney Stones
Keywords: NV-VPAC1 Prostate Cancer Urine Diagnostic test
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: NuView Diagnostics
First posted: 2018-08-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with biopsy-confirmed prostate cancer, patients with BPH, and patients with bladder/kidney stones

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Association between PSA levels and NV-VPAC1 test results.
timeFrame: 6 months
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Jay Bishoff, MD
role: PRINCIPAL_INVESTIGATOR
References: