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
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males 18-80 years of age
- •Biopsy-confirmed prostate cancer
- •Scheduled within 2 weeks for prostatectomy
- •Signed informed consent
排除标准
- •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.
结局指标
主要结局
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
时间窗: 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
次要结局
- Association between PSA levels and NV-VPAC1 test results.(6 months)
研究者
JAY BISHOFF
Director of Intermountain Urological Institute
Intermountain Health Care, Inc.