MRI Targeted Focal Laser Thermal Therapy of Prostate Cancer Followed by Radical Prostatectomy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Validity of MR/US Fusion and MR Targeting
研究概览
简要总结
This is a clinical research study designed to measure the effectiveness of focal Interstitial Laser Thermal Therapy (ILTT) at killing prostate tumours. Patients with "low risk" prostate cancer (Trans Rectal US Guided Biopsy positive) will undergo an MRI scan to try to localize the tumour. If the MRI detects the tumour they will then undergo a perineal ablative procedure (ILTT) under general anaesthetic. Seven days following ILTT they will come back to the hospital for a Radical Retoropubic Prostatectomy (RRP) procedure, which is the removal of a prostate gland through a surgical incision. After removal, the prostate will undergo further analysis to determine the exact location of cancer and evaluate the extent of cancer death caused by ILTT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men 40-80 years of age;
- •Histologically-proven prostate carcinoma;
- •Prostate cancer clinical stage T1c and T2a
- •Prostate MRI must confirm area suspicious for cancer in the sector of the positive biopsy;
- •A minimum of six (6) weeks between the prostate biopsy and the Inclusion Visit;
- •Prostate specific antigen (PSA) level 15 ng/mL
排除标准
- •Medically unfit for Radical Retropubic Prostectomy (RRP) surgery
- •Patients who are unwilling or unable to give informed consent;
- •Patients with foci location in the apex of the prostate or isolated transition zone cancers
- •Patients who have received androgen suppression therapy
- •Patients who have received or are receiving chemotherapy for prostate carcinoma;
- •Patients previously treated with surgery to the prostate (traditional, endoscopic or minimally invasive including HIFU, TUNA, RITA, microwave, TURP, cryotherapy or any curative treatment
- •Patients who have undergone radiation therapy for prostate cancer or to the pelvis
- •Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies);
- •Patients with a history of non compliance with medical therapy and/or medical recommendations;
研究组 & 干预措施
1
干预措施: Focal Phothtermal Ablation (Procedure)
结局指标
主要结局
Validity of MR/US Fusion and MR Targeting
时间窗: 7 Days after Focal Therapy
次要结局
未报告次要终点