MRI-Guided Active Selection for Treatment of Prostate Cancer: The Miami MAST Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Rate of Disease Progression Within the First Two Surveillance Biopsies
研究概览
简要总结
The main purpose of this study is to determine if Magnetic Resonance Imaging (MRI), along with MRI targeted biopsy of suspicious lesions, is of value in detecting patients who would be likely to require treatment earlier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 85 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 within 18 months prior to enrollment;
- •Pre-enrollment prostate biopsy must consist of at least 8 cores;
- •Biopsy reviewed by a University of Miami Pathologist;
- •Serum Prostate-Specific Antigen (PSA) ≤ 20 ng/ml within 3 months of study enrollment;
- •Age ≥ 35 and ≤ 85 years;
- •Ability to understand and willingness to sign a written informed consent document;
- •Patients must agree to undergo serial multiparametric MRI and MRI-guided biopsy;
- •Patients must agree to fill out the longitudinal psychosocial questionnaires assessing health related quality of life.
排除标准
- •Greater than 4 cores positive, of any Gleason score, on the University of Miami (UM) review,
- •Greater than 2 cores positive for Gleason 3+4 cancer,
- •Gleason 4+3 or higher cancer in any single biopsy core.
- •Extracapsular extension suspected on digital rectal exam with confirmation on MRI. Suspicion of extracapsular extension on MRI alone is not an exclusion for study enrollment.
- •Subject is not a candidate for multiparametric MRI with contrast. Some reasons may include (but are not limited to): renal insufficiency, foreign body or pacemakers.
- •No prior pelvic radiotherapy.
- •No prior surgery to the prostate, other than transurethral procedures for benign prostatic hyperplasia (e.g., transurethral resection, green light laser treatment).
- •No concurrent, active malignancy, other than non-metastatic skin cancer of any type, superficial bladder cancer, or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma) or <stage IV follicular lymphoma. If a prior malignancy is in remission for ≥ 3 years then the patient is eligible.
- •Bilateral hip replacement.
结局指标
主要结局
Rate of Disease Progression Within the First Two Surveillance Biopsies
时间窗: 24 months
The rate of disease progression among participants within the first two surveillance biopsies will be reported. Progression refers to a repeat surveillance biopsy indicating any one of the following: 1. More than 4 positive cores involving any grade of cancer, 2. At least two core with Gleason 3+4 cancer, 3. Any single core with Gleason 4+3 cancer or higher, 4. A Gleason 3+3 at diagnosis that is upgraded to Gleason 3+4, or 5. Undergoing treatment, regardless of histological progression.
次要结局
- Health-Related Quality of Life Scores: MAX-PC(Up to 36 months)
- Time-to-Biochemical Recurrence (BCR)(Up to 36 months)
- Health-Related Quality of Life Scores: EPIC SF-12(Up to 36 months)
- Discriminative Performance of NCCN Risk and Clinical Markers for Predicting Progression on Active Surveillance(Up to 36 months)
- Health-Related Quality of Life Scores: EPIC SF-12(Up to 36 months)
- Health-Related Quality of Life Scores: MAX-PC(Up to 36 months)
研究者
Sanoj Punnen, MD, MAS
Associate Professor
University of Miami