Clinical trial · Observational
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.
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Prostatic Hypertrophy | Benign Prostatic Hyperplasia | ALIAS | 0.90 |
| Bladder Stones | — | UNRESOLVED | — |
| Kidney Stones | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NV-VPAC1 PCa Urine Diagnostic Test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Prostate Cancer (PCa)
- description
- Comprised of men with biopsy-confirmed PCa who are scheduled for prostatectomy.
- interventionNames
- Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic Test
- label
- Benign Prostatic Hypertrophy (BPH)
- description
- comprosed of men with benign prostatic hypertrophy (BPH) who are scheduled for transurethral resection of the prostate (TURP).
- interventionNames
- Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic Test
- label
- Bladder/kidney stone
- description
- Comprised of men or women with bladder/kidney stones who are scheduled for a cystoscopy.
- interventionNames
- Diagnostic Test: NV-VPAC1 PCa Urine Diagnostic Test
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available