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.
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer, Orthopedic, Nephrology, Nephrology, Nephrology, Urology |
| Therapuetic Areas: | Nephrology / Urology, Oncology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 10/20/2018 |
| Start Date: | October 16, 2018 |
| End Date: | December 2019 |
| Contact: | Anne Haroldsen |
| Email: | Anne.Haroldsen@imail.org |
| Phone: | 801-507-9415 |
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.
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.
We found this trial at
1
site
5121 S Cottonwood St
Murray, Utah 84157
Murray, Utah 84157
(801) 507-7000
Principal Investigator: Jay Bishoff, MD
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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