Novel Screening MRI for the Detection of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Increased detection of clinically significant prostate cancer
研究概览
简要总结
This pilot clinical trial studies how well magnetic resonance imaging (MRI) before biopsy works in diagnosing patients with prostate cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. This diagnostic procedure may aid in identifying lesions in the prostate which may have cancer. The lesions can then be targeted during the prostate biopsy to improve the accuracy of identifying prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. Identification of one of more lesions suspicious for prostate cancer using a novel MRI protocol, not identified by transrectal ultrasound (TRUS) alone and to determine if the lesions identified by MRI demonstrate clinically significant prostate cancer based on pathologic findings (ie. Gleason >= 7 or percentage of core involved with cancer > 50%).
SECONDARY OBJECTIVES:
I. Average time for MRI scan per patient. II. Correlation of lesions on MRI to radical prostatectomy specimens. III. To determine whether MRI 3 dimensional (3D) T2 half-Fourier acquired single turbo spin-echo (HASTE) or sampling perfection with application optimized contrast using different flip angle evolutions (SPACE) protocols provide improved rates of prostate cancer detection.
IV. Yield of additional clinically significant prostate cancer diagnoses based on MRI targeted lesions on biopsy.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Abnormal prostate-specific antigen (PSA) blood test
- •> 2.5 ng/mL for men < 50 years (yrs) of age
- •> 3.5 ng/mL for men < 60 yrs of age
- •> 4.5 ng/mL for men < 70 yrs of age
- •Abnormal digital rectal exam (i.e. palpable nodule, induration or firm area to the prostate)
- •Scheduled for a TRUS biopsy based on clinical suspicion for prostate cancer
排除标准
- •Individuals who have previously undergone biopsy of the prostate for diagnosis of prostate cancer
- •Contraindications to TRUS/prostate biopsy (BX)
- •Currently on blood thinning agents (Plavix, Coumadin etc.) or bleeding disorder
- •Active urinary tract infection
- •Acute painful perianal disorder (i.e. rectal abscess)
- •Contraindications to MRI
- •Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips
- •The presence of an implanted pacemaker or implanted defibrillator device
- •Patients with contraindications for MRI due to embedded foreign metallic objects: bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient
- •Implanted medical device not described above that is not MRI-compatible
- •Known history of claustrophobia
- •Individuals with a short life expectancy (< 10 years)
结局指标
主要结局
Increased detection of clinically significant prostate cancer
时间窗: Up to 1 year
Percent increase of patients with positive prostate cancer biopsies detected with pelvic MRI quick scan from the anticipated detection rate of 40%
次要结局
- Detection of clinically significant prostate cancer using 3D T2 SPACE(Up to 1 year)
- Detection of clinically significant prostate cancer using 3D T2 HASTE(Up to 1 year)