JPRN-jRCT2052210088进行中（未招募）3 期
Prostate Cancer Lesion Targeted Cryoablation: Investigator Initiated Trial - PROCRY
kimura Osamu0 个研究点目标入组 50 人开始时间: 2021年9月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 85age old（—）
- 性别
- Male
入选标准
- •1) Patients who have a PI-RADS category 3 or 4 lesion on MRI image at enrollment and who have a single lesion with a Gleason score 7 or 8 on histopathology of the prostate needle biopsy at enrollment; or, patients who have a PI-RADS category 4 or 5 lesion on MRI image at enrollment and who have a single lesion with a Gleason score 6 or 7 on histopathology of the prostate needle biopsy at enrollment
- •2) Patients with prostate cancer that is clinical stage T2c or lower (T1a-T2cN0M0) according to the TNM Classification as determined during enrollment
- •3) Patients between the ages of 20 and 85 when providing consent to participate in this trial
- •4) Patients from whom consent is obtained prior to enrollment in this trial
排除标准
- •1) Patients to have a lesion identified as PI-RADS category 4 or 5 on MRI images at enrollment and who have a single lesion with a diameter of less than 10 mm and Gleason score of 6 on the histopathology of the prostate needle biopsy at enrollment (the lesion is referred to as `non-target lesions`) (the diameter of the lesion is defined as the longer one of the lesion diameter identified on MRI images at enrollment or the tumor length as measured on histopathology of prostate needle biopsy)
- •2) Patients to have 4 or more non-target lesions (non-target lesions are defined as the lesions defined in exclusion criterion 1, or lesions with PI-RADS category 3 on MRI image at enrollment and Gleason score 6 on biopsy at enrollment)
- •3) Patients to have a lesion with PI-RADS category 5 on MRI image at enrollment and Gleason score 8 on histopathology of prostate needle biopsy at enrollment (the lesion is referred 'excluded lesions')
- •4) Patients with a serum prostate-specific antigen (PSA) level over 20 ng/ml during enrollment
- •5) Patients in whom the distance from the target prostate cancer lesion to an external urinary sphincter is 5 mm or less on MRI images (coronal or sagittal) obtained during enrollment
- •6) Patients who have undergone surgery, drug therapy, or radiation therapy for prostate cancer prior to enrollment
- •7) Patients who have received an antiandrogen for benign prostatic hyperplasia prior to enrollment
- •8) Patients using absorbent pads or adult diapers due to urge incontinence
- •9) Patients with active multiple cancers
- •10) Patients for whom MRI scans are contraindicated
- •11) Patients in whom transrectal ultrasound cannot be performed for some reason, such as a constricted rectum
- •12) Patients with a prothrombin time<50% or platelet count<60,000/mm3 during enrollment
- •13) Patients deemed to be ineligible by an investigator
研究者
相似试验
已完成
不适用
Prostate Cancer Lesion Targeted Cryoablation: Investigator Initiated Trialocalized prostate cancerJPRN-UMIN000032554Kyoto Prefectural University of Medicine51
进行中（未招募）
不适用
Targeted Cryoablation of Prostate Cancer Lesions: An Investigator-initiated TrialProstate CancerNCT05500846Osamu Ukimura51
招募中
2 期
Focal cryotherapy for prostate cancerProstate cancer, cryotherapy, focal therapyProstate cancerJPRN-jRCTs032180392Kimura Takahiro60
招募中
2 期
An Evidence-Based Focal Cryotherapy Protocol for Focal Ablation of Intermediate Risk Prostate CancerProstate CancerNCT05454488M.D. Anderson Cancer Center30
进行中（未招募）
不适用
Phase II Trial of Focal Cryotherapy for Prostate CancerProstate CancerNCT04138914Singapore General Hospital30