Prostate CancerVPACNCT03630926
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.
An observational study of Prostate Cancer and Benign Prostatic Hypertrophy, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prostate Cancer, Benign Prostatic Hypertrophy, Bladder Stones
- What is being tested?
- NV-VPAC1 PCa Urine Diagnostic Test
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2018to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with biopsy-confirmed prostate cancer, patients with BPH, and patients with bladder/kidney stones
Who may be able to join
- Males 18-80 years of age
- 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)
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- 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
Who cannot join
- 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
- Presence or history of any cancer diagnosis, with the exception of certain skin cancers
- Currently treated with finasteride (Proscar®, Propecia®) or dutasteride (Avodart®)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- NV-VPAC1 PCa Urine Diagnostic Test
- Keywords
- NV-VPAC1 Prostate Cancer Urine Diagnostic test
- Medical subject headings
- Prostatic Neoplasms, Prostatic Hyperplasia, Urinary Bladder Calculi, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NV-VPAC1 PCa Urine Diagnostic TestDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer (PCa) | Comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy. Receives: Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic Test | |
| Benign Prostatic Hypertrophy (BPH) | comprosed of men with benign prostatic hypertrophy (BPH) who are scheduled for transurethral resection of the prostate (TURP). Receives: Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic Test | |
| Bladder/kidney stone | Comprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy. Receives: Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Association between PSA levels and NV-VPAC1 test results.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start16 Oct 2018
- Primary completionAug 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- NuView Diagnostics
- Responsible party
- Principal investigator, JAY BISHOFF, Intermountain Health Care, Inc.
- Investigators
- Jay Bishoff, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630926
- Sponsor's protocol ID
- VPAC
- Acronym
- VPAC
- Status last verified
- Apr 2019
- First submitted
- 10 Aug 2018
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03630926
- Acronym / sponsor ID
- VPAC / VPAC
- Keywords
- NV-VPAC1 Prostate Cancer Urine Diagnostic test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- NuView Diagnostics
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer (PCa) | – | Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic TestComprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy. |
| Benign Prostatic Hypertrophy (BPH) | – | Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic Testcomprosed of men with benign prostatic hypertrophy (BPH) who are scheduled for transurethral resection of the prostate (TURP). |
| Bladder/kidney stone | – | Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic TestComprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biopsy-confirmed prostate cancer, patients with BPH, and patients with bladder/kidney stones
Key inclusion criteria (12 listed)
- Males 18-80 years of age
- Biopsy-confirmed prostate cancer
- Scheduled within 2 weeks for prostatectomy
- Signed informed consent
- Males 18-80 years of age
Key exclusion criteria (10 listed)
- 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
- Presence or history of any cancer diagnosis, with the exception of certain skin cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NV-VPAC1 PCa Urine Diagnostic TestThe 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. | Diagnostic test | Benign Prostatic Hypertrophy (BPH), Bladder/kidney stone, Prostate Cancer (PCa) |
Primary outcome
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
Time frame: 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
1 secondary outcome
Association between PSA levels and NV-VPAC1 test results.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay Bishoff, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Benign Prostatic Hypertrophy, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.