Feasibility and Efficacy of Upright MP - MRI for Prostate Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- PSA levels
研究概览
简要总结
This is an investigator initiated study to test the efficacy of an upright MRI (Magnetic Resonance Imaging) for the screening of prostate cancer. The purpose of this study is to compare Upright MRI as a technique to PSA (Prostate Specific Antigen) and current MRI imaging. It will take place at Mount Sinai Hospital, and last for a total of about 5 years. Eligible patients will be determined by the urologist. The target population is men who are at risk for prostate cancer, as determined by the urologist. Diagnostic criteria will include elevated PSA and an abnormal digital rectal exam (DRE). After patients are screened and determined eligible, they will be asked to have a seated MRI using the Indomitable Magnetic Resonance Imaging Scanner, Ex vivo magnetic resonance imaging using 0.6 T strength, as well as a standard of care closed 3T MRI. After each scan, the patient will be given a series of questionnaires to assess their comfort level during the scan. Patients will be followed every 6 months after completion of (or early withdrawal from) study enrollment until 5 years.
详细描述
Prostate cancer (PCa) is the second most common cancer among men in the United States, with over 180,000 new cases diagnosed in 2016. This commonality implies that set standards need to be set and devise effective tools to screen and diagnose prostate cancer. Today, prostate specific antigen (PSA) test is the most widely adopted screening method for PCa. Since its introduction in 1979, it has helped in earlier diagnosis of PCa and has had a marked shift on the stage at which PCa is identified. PSA, although popular as a screening tool, has several shortcomings. It is organ-specific rather than cancer-specific, which means that its values can be elevated even for non-malignant conditions . Indeed, PSA based screening has reported positive predictive value as low as 30% (PSA cutoff >4.0 ng/dL) for detecting prostate cancer and an over diagnosis rate of 50%, which leads to unnecessary biopsies and aggressive treatments of men with clinically indolent (insignificant) disease.
Current diagnostic pathway of prostate cancer requires men with elevated PSA and abnormal Digital Rectal exam to undergo a Trans Rectal Ultra Sound (TRUS) guided biopsy. TRUS is a blind-systematic biopsy, which randomly samples prostate tissue. This can lead to missing or under-diagnosing clinically significant cancer and over-diagnosing clinically insignificant disease. TRUS biopsy is itself associated with morbidity, mainly in the form of hematuria, hematospermia, pain, urinary retention and sometimes can cause life-threatening sepsis.
Many of the PSA screened detected prostate cancers detected on TRUS are clinically insignificant and even if left untreated have little to no clinical impact on an individual's remaining life. Overtreatment resulting from over diagnosis often leads to side effects like erectile dysfunction (approx. 60%) from radical therapy and urinary incontinence.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men at risk of prostate cancer and have been advised to have a prostate MRI.
- •Age ≥ 18 years.
- •Fit for undergoing all study protocol procedures which includes an ultrasound guided biopsy.
- •Able to tolerate general or spinal anesthesia.
- •Ability to understand and the willingness to sign a written informed consent and to comply with the protocol.
排除标准
- •Patients who have been treated using 5- alpha-reductase inhibitors at the time of study enrollment or 6 months prior to enrollment.
- •Patients with previous history of prostate biopsy, prostate surgery or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction is acceptable)
- •Patients who have evidence of a urinary tract infection or history of acute prostatitis within the last 3 months.
- •Patients contraindicated to undergoing the MRI procedure e.g. pacemaker, estimated GFR<=50, automatic implantable cardiac defibrillators.
- •History of any other medical condition precluding procedures described in the protocol
结局指标
主要结局
PSA levels
时间窗: 5 years
Prostate-specific Antigen (PSA) levels
次要结局
- Diagnostic Yield of MRI and PSA Density(5 years)
- Number of Correctly Identified side(5 years)
- Upright MRI compared to Standard MRI(5 years)
- Claustrophobic Questionnaire (CLQ)(5 years)
- Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ)(5 years)
- NCCN Distress Thermometer(5 years)
研究者
Ashutosh Kumar Tewari
Professor
Icahn School of Medicine at Mount Sinai
