DNA Methylation in Adenocarcinoma of the Prostate: Analysis of Validated Biomarkers in Urine
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Accuracy of methylated DNA markers (MDMs) for detection of cancer of the prostate (CAP)
研究概览
简要总结
This study explores the potential use of DNA markers in the detection of prostate cancer and patient perceptions of this screening approach and other current or future prostate cancer screening and diagnostic tests.
详细描述
PRIMARY OBJECTIVE:
I. To assess the accuracy of MDM candidates (individually and in combination) assayed from urine and prostatic fluid (collected following digital prostate massage) for detection of CAP.
OUTLINE: This is an observational study.
PHASE I: Participants undergo urine sample collection on study.
PHASE II: Participants undergo standard prostate massage and collection of prostatic fluid and urine samples on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •* Patient is 18 years or older
- •Patient has a histologically confirmed diagnosis of prostatic carcinoma/adenocarcinoma with a corresponding Gleason score OR is scheduled for a prostate biopsy for an elevated Prostate Specific Antigen (PSA), palpable prostate nodule, an abnormal imaging finding, or worrisome PSA velocity
排除标准
- •* Patient has had a transplant prior to sample collection
- •Patient has had Androgen (e.g. Flutamide, Androcur, Casodex, Nilandron) or Luteinizing hormone-releasing hormone (LHRH) (e.g. Lupron, Zoladex) therapy
- •Patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within the 7 days prior to sample collection
- •Patient has chronic indwelling urinary catheter
- •Patient has had a urinary tract infection within the 14 days prior to sample collection
- •Patient has immunotherapy (e.g. Kwon study drugs) for prostate cancer prior to sample collection
- •Patient has a history of bladder cancer
- •Patient has had a biopsy within the last 6 weeks (excluding non-melanoma skin biopsies) of sample collection
- •Patient has had surgery to completely remove current target pathology prior to sample collection
- •Patient has a prior history of prostate carcinoma/adenocarcinoma
- •Patient has received chemotherapy class drugs (e.g. Docetaxel, Methotrexate) within the 5 years prior to sample collection
- •Patient has received therapeutic radiation prior to sample collection
- •Patient has had focal ablation [e.g. High-intensity focused ultrasound (HIFU) or cryoablation] of prostate cancer prior to sample collection
- •Patient has known primary cancer outside of the prostate within the last 5 years (not including basal cell or squamous cell skin cancers) of sample collection
结局指标
主要结局
Accuracy of methylated DNA markers (MDMs) for detection of cancer of the prostate (CAP)
时间窗: Baseline
Assessed by instances of CAP detected using MDMs assayed from urine (Phase I) and from urine and prostate fluid (collected following digital prostate massage for participants in Phase II) for detection of CAP.
次要结局
- Accuracy of CAP detection(Baseline)
- Comparison of sample volumes(Baseline)