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 Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Prostate Cancer (PCa) Comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy. |
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.
|
| 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
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.
|
| 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
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.
|
Outcome Measures
Primary Outcome Measures
- 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 [6 months]
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
Secondary Outcome Measures
- Association between PSA levels and NV-VPAC1 test results. [6 months]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Intermountain Medical Center | Murray | Utah | United States | 84107 |
Sponsors and Collaborators
- Intermountain Health Care, Inc.
- NuView Diagnostics
Investigators
- Principal Investigator: Jay Bishoff, MD, Intermountain Health Care, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VPAC