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.
NCT ID: NCT03630926
Last Updated: 2019-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
45 participants
OBSERVATIONAL
2018-10-16
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Prostate Cancer (PCa)
Comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy.
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).
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Biopsy-confirmed prostate cancer
* Scheduled within 2 weeks for prostatectomy
* Signed informed consent
* 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
* Males or females 18-80 years of age
* Diagnosed with bladder/kidney stones
* Scheduled within 2 weeks for cystoscopy
* Signed informed consent
Exclusion Criteria
* 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
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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NuView Diagnostics
UNKNOWN
Intermountain Health Care, Inc.
OTHER
Responsible Party
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JAY BISHOFF
Director of Intermountain Urological Institute
Principal Investigators
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Jay Bishoff, MD
Role: PRINCIPAL_INVESTIGATOR
Intermountain Health Care, Inc.
Locations
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Intermountain Medical Center
Murray, Utah, United States
Countries
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Other Identifiers
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VPAC
Identifier Type: -
Identifier Source: org_study_id
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