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.

I

Intermountain Health Care, Inc.

Status

Unknown

Conditions

Benign Prostatic Hypertrophy
Bladder Stones
Kidney Stones
Prostate Cancer

Treatments

Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic Test

Study type

Observational

Funder types

Other

Identifiers

NCT03630926
VPAC

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

45 participants in 3 patient groups

Prostate Cancer (PCa)
Description:
Comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy.
Treatment:
Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic Test
Benign Prostatic Hypertrophy (BPH)
Description:
comprosed of men with benign prostatic hypertrophy (BPH) who are scheduled for transurethral resection of the prostate (TURP).
Treatment:
Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic Test
Bladder/kidney stone
Description:
Comprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy.
Treatment:
Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic Test

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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