Examination of Focal Therapies - MRI-Fusion, HIFU, NanoKnife and Cryotherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 主要终点
- Prostate cancer detection rate and clinically significant prostate cancer detection rate of MRI-US FUSION biopsy.
研究概览
简要总结
The main objective of this study is to determine whether focal-driven therapies for diagnosis and treatment of prostate cancer are preferable over current clinical methods. Different focal procedures will be examined, including magnetic resonance imaging (MRI)-target biopsy, and focal treatment as High Intensity Focused Ultrasound (HIFU), cryoablation and Nano-Knife.
详细描述
Men who are scheduled to undergo a focal therapy will be given patient information sheet, which explains the study in lay terms. Fully informed consent, written or verbal (by phone) will be sought and documented before collecting any research data.
The following information will be collected for all patients:
- Demographic data: date of birth, age, gender, ethnicity, Height, weight.
- Medical History: number and results of previous biopsies, previous Protein Specific Antigen (PSA) tests.
For patients who have undergone or are scheduled to undergo MRI-US FUSION biopsy, the following information will be collected:
- MRI: MRI protocol, MRI results: suspected lesions, apparent diffusion coefficient (ADC) values.
- Biopsy procedure details and results: duration and success of procedure, number of cores taken, pathological results, following treatment (if applicable).
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men who have underwent, or are scheduled to undergo a focal therapy treatment at Ramat Aviv Medical Center or Rabin Medical Center
排除标准
- 未提供
结局指标
主要结局
Prostate cancer detection rate and clinically significant prostate cancer detection rate of MRI-US FUSION biopsy.
时间窗: 5 years
clinically significant prostate cancer is defined as Gleason 7 and above
PSA change after focal therapy (HIFU, Nano-Knife and Cryotherapy)
时间窗: 5 years
PSA will be taken every 3 months during the first year after procedure, and every 6 months in the next following 4 years
次要结局
- Change in erectile function measured by International Index of Erectile Function (IIEF-5) questioner(5 years)
- Change in urinary symptoms measured by International Prostate Symptom Score (IPSS) questioner(5 years)