Upright MRI for Prostate Cancer Screening
关键词
抽象
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.
日期
| 最后验证: | 03/31/2020 |
| 首次提交: | 03/15/2018 |
| 提交的预估入学人数: | 03/15/2018 |
| 首次发布: | 03/22/2018 |
| 上次提交的更新: | 04/28/2020 |
| 最近更新发布: | 04/30/2020 |
| 实际学习开始日期: | 07/31/2018 |
| 预计主要完成日期: | 07/31/2024 |
| 预计完成日期: | 07/31/2024 |
状况或疾病
干预/治疗
Device: Upright MRI
Device: MRIs in random order
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Standard MRI first Patients will have a standard of care MRI, then consent to study participation and have an upright MRI. | |
| MRIs in random order Patients will consent to participate in the study, then do two MRIs in random order. | Device: MRIs in random order standard of care closed 3T MRI |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | Male |
| 取样方式 | Non-Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
结果
主要结果指标
1. PSA levels [5 years]
次要成果指标
1. Upright MRI compared to Standard MRI [5 years]
2. Claustrophobic Questionnaire (CLQ) [5 years]
3. NCCN Distress Thermometer [5 years]
4. Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ) [5 years]
5. Diagnostic Yield of MRI and PSA Density [5 years]
6. Number of Correctly Identified side [5 years]
