Evaluation of a Novel, Non-Invasive Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and Patients at Risk of Harboring Low-Risk Prostate Cancer: A Prospective Non-Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria)
研究概览
简要总结
The purpose of this study is to examine the use of MRI surveillance for patients with no prostate cancer, potential prostate cancer, or diagnosed low-grade prostate cancer.
详细描述
This study will use MRI instead of prostate biopsy in combination with regularly scheduled urologist visits, interval PSA checks, and annual DRE to help establish a non-invasive method for 1) participants with a negative prostate MRI (PI-RADS 1 or 2) who have never had a biopsy; 2) participants with a positive MRI (PI-RADS score of 3, 4, or 5) and negative MRI-targeted biopsy pathology; and 3) monitoring participants with clinically diagnosed low risk prostate cancer who are on active surveillance. However, if at any point, clinical suspicion indicated either by the presence of suspicious lesions on the MRI, rising PSA, and/or positive DRE arises, then an immediate biopsy will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy-naive patients with a negative prostate MRI (PI-RADS score 1 or 2); or
- •Patients with a PI-RADS score of 3, 4, or 5 on MRI and a negative MR-targeted biopsy; or
- •Patients on active surveillance with a negative prostate MRI (PI-RADS 1 or 2).
排除标准
- •Positive DRE;
- •PSA > 10 ng/ml or unstable PSA (doubling time <3 years) during the last year prior to enrolling in this study;
- •PSAD > 0.15 (calculated using most recent PSA divided by MRI prostate volume);
- •First degree relative diagnosed with prostate cancer
- •First degree relative diagnosed with a BRCA2 or Lynch syndrome associated gene causing any cancer.
- •Patient carries a mutation on BRCA2 or a mismatch repair gene associated with Lynch syndrome (MLHl, MSH2, MSH6, PMS2); known BRCA2 or known mismatch repair gene mutation in the family (Lynch Syndrome) and patient has not had testing; or family history consistent with BRCA2 or Lynch syndrome and there is no known BRCA2 or mismatch repair gene in the family.
研究组 & 干预措施
Virtual prostate biopsy (VB) monitoring
Prostate-specific antigen (PSA) and digital rectal exam (DRE) are standard of care for monitoring patients on active surveillance or at risk of having low-risk prostate cancer. A novel virtual biopsy (VB) monitoring protocol will be implemented:
- PSA bi-annually or more often according to the discretion of the urologist.
- Annual DRE.
- Visit with the urologist bi-annually.
- Multi-parametric MRI (mpMRI) every year for 3 years.
- Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year.
干预措施: virtual biopsy (VB) monitoring protocol (Diagnostic Test)
结局指标
主要结局
Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria)
时间窗: Up to 3 years from start of study
Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria). This metric will determine if the the VB protocol is statistically equal to (or greater than) the negative predictive value of the standard of care TRUS prostate biopsy.
次要结局
未报告次要终点