Diagnosing Clinically Significant Prostate Cancer in African American and White Men Phase II, Randomized Clinical Trial, Multi-center, MR-Guided vs. 12-core Systematic Random Biopsy, Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 288
- 试验地点
- 8
- 主要终点
- Biopsy detection rate of clinically significant prostate cancer
研究概览
简要总结
This randomized phase II trial studies how well systematic random biopsy or magnetic resonance imaging (MRI)-ultrasound image (US) fusion biopsy work in diagnosing prostate cancer in patients with elevated prostate specific antigen. Systematic random biopsy and MRI-US fusion biopsy may work better in improving the accuracy of prostate cancer detection.
详细描述
PRIMARY OBJECTIVES:
I. To compare the detection of clinically significant prostate cancer (CSPCa) in Arm 1 versus Arm 2.
II. To compare between African American (AA) and white men the probability of developing CSPCa within three years of initial biopsy at the start of the study.
SECONDARY OBJECTIVES:
I. To determine complications and patient morbidity associated with either systematic random prostate biopsy (SR-Bx) versus (vs) magnetic resonance imaging-ultrasound image fusion biopsy (MRUS-Bx) + SR-Bx.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
- •Note: HIPAA authorization may be included in the informed consent or obtained separately
- •Eastern Cooperative Oncology Group (ECOG) performance status of =< 1 within 3 months (93 days) prior to being registered for protocol
- •African-American or white men (Hispanic or non-Hispanic)
- •Prostate biopsy-naive or a single negative biopsy
- •Having elevated prostate specific antigen (PSA) (> 2.5 ng/ml) and no palpable nodule on digital rectal exam (DRE)
- •Ability to understand the willingness to sign a written informed consent
- •Patients must be willing to undergo a radiologic imaging before and after biopsy of the prostate
- •Patients must be willing to undergo a biopsy of the prostate
排除标准
- •Patients who have had chemotherapy or radiotherapy within 12 months of the study for other diagnoses not related to prostate cancer
- •Patients receiving any other investigational agents
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Patients with active inflammatory bowel disease
- •Patients who are unable to undergo MRI
- •Patients who had any surgery of the prostate including TURP (transurethral resection of the prostate)
- •Patients who had > 1 prior prostate biopsy
研究组 & 干预措施
Arm I (SR-Bx)
Patients undergo SR-Bx. If SR-Bx doesn't reveal clinically significant cancer, then MRI will be done in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx. If there is no lesion, then no biopsy. Schedule MRI in 12 months after the initial MRI.
干预措施: Biopsy of Prostate (Procedure)
Arm I (SR-Bx)
Patients undergo SR-Bx. If SR-Bx doesn't reveal clinically significant cancer, then MRI will be done in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx. If there is no lesion, then no biopsy. Schedule MRI in 12 months after the initial MRI.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (SR-Bx)
Patients undergo SR-Bx. If SR-Bx doesn't reveal clinically significant cancer, then MRI will be done in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx. If there is no lesion, then no biopsy. Schedule MRI in 12 months after the initial MRI.
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
Arm I (SR-Bx)
Patients undergo SR-Bx. If SR-Bx doesn't reveal clinically significant cancer, then MRI will be done in 3 months, and if lesion is present (PIRADS ≥ 3) schedule for MRUS-Bx. If there is no lesion, then no biopsy. Schedule MRI in 12 months after the initial MRI.
干预措施: MRI Ultrasound Fusion Guided Biopsy (Diagnostic Test)
Arm II (MRI, MRUS-Bx, SR-Bx)
Patients undergo MRI. Must be scheduled at least one day before MRUS biopsy.
- If MRI shows no lesion present (PIRADS 1-2), then no MRUS-Bx. Schedule for SR-Bx only.
- If MRI shows lesion present (PIRADS ≥ 3), perform MRUS-Bx, which will be done first and followed immediately by SR-Bx.
干预措施: Biopsy of Prostate (Procedure)
Arm II (MRI, MRUS-Bx, SR-Bx)
Patients undergo MRI. Must be scheduled at least one day before MRUS biopsy.
- If MRI shows no lesion present (PIRADS 1-2), then no MRUS-Bx. Schedule for SR-Bx only.
- If MRI shows lesion present (PIRADS ≥ 3), perform MRUS-Bx, which will be done first and followed immediately by SR-Bx.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (MRI, MRUS-Bx, SR-Bx)
Patients undergo MRI. Must be scheduled at least one day before MRUS biopsy.
- If MRI shows no lesion present (PIRADS 1-2), then no MRUS-Bx. Schedule for SR-Bx only.
- If MRI shows lesion present (PIRADS ≥ 3), perform MRUS-Bx, which will be done first and followed immediately by SR-Bx.
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
Arm II (MRI, MRUS-Bx, SR-Bx)
Patients undergo MRI. Must be scheduled at least one day before MRUS biopsy.
- If MRI shows no lesion present (PIRADS 1-2), then no MRUS-Bx. Schedule for SR-Bx only.
- If MRI shows lesion present (PIRADS ≥ 3), perform MRUS-Bx, which will be done first and followed immediately by SR-Bx.
干预措施: MRI Ultrasound Fusion Guided Biopsy (Diagnostic Test)
结局指标
主要结局
Biopsy detection rate of clinically significant prostate cancer
时间窗: Up to 5 years
Will code patients as having clinically significant prostate cancer if they are diagnosed with Gleason score \>= 7 or any Gleason score with core length \>= 5 mm or any Gleason score that includes Gleason pattern \>= 4 at initial systematic random biopsy.
次要结局
- Presence of any of the complications(Up to 5 years)