NCT01838265撤回不适用
A Randomized Two-Arm Trial of Prostate Cancer Patients Undergoing Active Surveillance With or Without MRI-Guided Management: The MGM Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rate of Progression in Subjects undergoing MRIus Biopsy vs Standard Ultrasound biopsy
研究概览
简要总结
- Using multiparametric MRI Ultrasound-guided or MRI-guided biopsies will allow more accurate sampling of the tumors and therefore will increase the rate of "progression" on early (first and second) surveillance biopsies and decrease the rate of "progression" on late (third and further) surveillance biopsies compared to Transrectal Ultrasound-guided biopsies.
- Quality of life (QoL) will be similar in patients undergoing MRI Ultrasound or MRI-guided and Transrectal Ultrasound-guided biopsies.
- Biomarker expression levels will correlate with biopsy progression.
详细描述
Favorable risk patients will be randomized to one of two active surveillance arms. Stratification will be based on Prostate-specific antigen density (PSAD) (=< 0.15 vs > 0.15 ng/mL per mL), and number of positive cores in the diagnostic biopsy (1 vs 2):
- Arm I: Active Surveillance Alone (AS). TRUS guided biopsies at start (within 6 months of enrollment) and at yearly intervals thereafter up to 36 months after the initial biopsy (maximum four biopsies).
- Arm II: MRI-Managed Active Surveillance (MRI-AS). MRIus or MRI-guided biopsies at start (within 6 months of enrollment) and at yearly intervals thereafter up to 36 months after the initial biopsy (maximum four biopsies).
Patients will also complete Quality of Life (QoL) assessments to provide unique data on the effects of MRI monitoring for patients undergoing active surveillance on QOL. The investigators have selected a group of measures that have been used extensively in prostate cancer populations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy confirmed adenocarcinoma of the prostate.
- •Biopsy must consist of at least 8 cores.
- •Enrollment is =< 1 year from diagnosis.
- •One or two biopsy cores with less than 50% tumor present in each core and Gleason score =< 6 (3+3).
- •Candidate for multiparametric MRI.
- •T1-T2a disease based on digital rectal exam.
- •No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for >= 5 years then the patient is eligible.
- •Ability to understand and willingness to sign a written informed consent document
- •Zubrod performance status <
- •Patients must agree to fill out the psychosocial questionnaires.
- •Age >= 35 and =< 75 years
排除标准
- •Not biopsy confirmed adenocarcinoma of the prostate.
- •Biopsy consists of less than 8 cores.
- •Three or more biopsy cores are positive.
- •Gleason score >= 3+4=
- •A single core has >= 50% involvement with Gleason score =6 (3+3) or less.
- •DCE-MRI study before enrollment.
- •Inability to undergo MRI exam.
- •Greater than T2a disease based on digital rectal exam.
- •Concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for < 5 years then the patient is ineligible
- •Inability to understand or unwilling to sign a written informed consent document.
- •Zubrod performance status >=
- •Patient unwilling to fill out the psychosocial questionnaires.
- •Age < 35 or > 75.
结局指标
主要结局
Rate of Progression in Subjects undergoing MRIus Biopsy vs Standard Ultrasound biopsy
时间窗: 42 months
To determine of multiparametric MRIus-guided biopsies increase the rate of progression on early (first two) biopsies in men undergoing active surveillance as compared with early detection using standard ultrasound biopsy.
次要结局
- Expression Levels of Biomarkers from biopsies collected with MRI-us Biopsy vs Standard Ultrasound Biopsy(42 months)
- Effect of MRI Monitoring on Health-Related Quality of Life(42 months)
研究者
Sanoj Punnen
Assistant Professor
University of Miami
研究点 (1)
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