NCT02564549终止不适用
Multiparametric MRI-Based Active Surveillance to Avoid the Risks of Serial Biopsies in Men With Low-Risk Prostate Cancer (MAVERICK)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- To asses the detection rate of Gleason score ≥ 4+3 in patients with low-risk prostate cancer who undergo transrectal ultrasound (TRUS) biopsy-based active surveillance (Group 1) versus patients who undergo mpMRI-based active surveillance (Group 2).
研究概览
简要总结
Phase II non-inferiority randomized trial of annual systematic biopsies versus mpMRI and targeted biopsies for men with low risk prostate cancer on active surveillance with any volume Gleason's Score 6, but no prior MRI imaging of the prostate.
详细描述
This is an unblinded, randomized trial of TRUS biopsy-based active surveillance versus mpMRI-based active surveillance. Patients on the TRUS biopsy-based arm will undergo annual systematic biopsies without any MRI staging or guidance. Patients on the mpMRI- based arm will undergo annual mpMRI surveillance imaging, with image-guided targeted biopsies only as indicated by radiographic findings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate adenocarcinoma diagnosed by biopsy within 12 months prior to study registration.
- •Gleason score ≤ 6
- •PSA < 10 ng/mL
- •Completed and documented history and physical addressing all inclusion/exclusion criteria.
排除标准
- •A diagnosis of prostate adenocarcinoma on more than one set of prostate biopsies, on separate calendar dates.
- •Previous MRI imaging of the prostate.
- •Prior history of pelvic radiotherapy.
- •Prior history of prostatectomy.
- •Contraindication to prostate mpMRI (renal failure, hip prosthesis, pacemaker, etc).
- •Contraindication to prostate biopsy via transrectal or transperineal approaches (including coagulopathy).
- •Patients on testosterone replacement therapy who are unwilling to discontinue.
- •Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements.
- •Unable to understand, or unwilling to complete the informed consent process.
研究组 & 干预措施
Group 1 (TRUS-guided biopsy)
Active Comparator
- Baseline and annual systematic TRUS-guided biopsy performed as per standard of care by urologists for a total of one baseline diagnostic biopsy and two active surveillance systematic biopsies.
- mpMRI at the end of the 2nd year with targeted biopsy of any Prostate Imaging Reporting and Data System (PI-RADS) 4 or 5 lesion. Patients needing image- guided targeted biopsies will undergo this procedure by interventional radiology, which is a common standard of care at HHM VAMC.
- Optional transperineal template biopsy of the prostate performed at end of 2nd year (month 25-30).
- Patients will be followed, as per standard of care, for any potential infections from biopsies.
- Annual PSA tests performed as per routine standard of care.
干预措施: TRUS-guided biopsy (Procedure)
Group 2 (mpMRI with targeted biopsy)
Experimental
- Baseline systematic transrectal ultrasound-guided biopsy performed as per standard of care by urologists.
- Baseline and annual mpMRI with targeted biopsy of any Prostate Imaging Reporting and Data System (PI-RADS) 4 or 5 lesion. Patients needing image- guided targeted biopsies will undergo this procedure by interventional radiology, which is a common standard of care at HHM VAMC.
- Optional transperineal template biopsy of the prostate performed at end of 2nd year (month 25-30).
- Patients will be followed, as per standard of care, for any potential infections from biopsies.
- Annual PSA tests performed as per routine standard of care.
干预措施: mpMRI with targeted biopsy (Procedure)
结局指标
主要结局
To asses the detection rate of Gleason score ≥ 4+3 in patients with low-risk prostate cancer who undergo transrectal ultrasound (TRUS) biopsy-based active surveillance (Group 1) versus patients who undergo mpMRI-based active surveillance (Group 2).
时间窗: 3 years
次要结局
- Percentage of patients in Group 1 versus Group 2 who remain on active surveillance from the time of randomization until the end of study participation.(3 years)
- To compare the rate of biopsy-related infections in Group 1 versus Group 2.(3 years)
- To compare the missed rate of occult Gleason score ≥ 4+3 by template biopsy at end of study in Group 1 versus Group 2.(3 years)
研究者
研究点 (2)
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