Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Oncological Control
研究概览
简要总结
Registration of Prostate Cancer patients undergoing Prostate Cryotherapy guided by Mutiparametric-MRI (MP-MRI) highlighting biopsy confirmed regions. The primary outcome measure is 5 year oncological control. Secondary aim is lack of progression beyond the prostate gland. The aim of intervention is to eradicate prostate cancer disease in the treated area while imposing no or minimal deleterious effects in quality of life.
详细描述
CLINICAL TRIAL OF OBSERVATION NATURE
PRIMARY OUTCOME
Cancer control of treated areas 5, 10, 15 years after intervention based on prostate biopsy of initial treated area, progression requiring conversion to radical prostate surgery or radiation or other forms of whole gland treatment (ej, HIFU), Metastatic Free survival: CT Scan and Bone Scans, Cancer-Specific and Overall Survival
SECONDARY OUTCOMES
Secondary Interventions focal interventions due to de-novo lesions. Focal or target therapy rescue with other technologies (ej HIFU); Short, Intermediate and Long-Term Urinary and Sexual Function changes in quality of life measured by validated inventories; Anxiety related to cancer and cancer control. Treatment tolerance to local anesthesia. Patient App compliance and activity to monitor care
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men between 55 and 65 years of age with a clinical diagnosis of prostate cancer with Low or Intermediate risk prostate cancer, and <50% positive core rate by prostate lobe
- •Men older than 65 years of age with clinical diagnosis of prostate cancer <50% positive core rate by prostate lobe
- •Absence of extra-capsular extension
- •Absence of seminal vesicle invasion
- •Absence of regional or distant metastatic disease
- •Multiparametric MRI of the prostate performed either before the biopsy or >10 weeks after prostate biopsy
- •Treated with Cryotherapy of the prostate
- •Treatment based on co-registration between MP-MRI and Prostate Ultrasound
排除标准
- •Prior treatment of prostate cancer in the form of surgery.
- •Performance status greater than 0 based on ECOG criteria
- •Mental status impairment
结局指标
主要结局
Oncological Control
时间窗: 1 Year
Lack of prostate cancer presence in treated area after MRI/US FUSION Biopsy
次要结局
- Urinary Functional Outcomes(Every 3 months up to 24 months)
- Sexual Functional Outcomes(Every 3 months up to 24 months)
- Oncological Control(Yearly, up to 10 years)
- Perioperative Outcomes(30 days)