NCT04379362Unknown2 期
Magnetic Resonance Imaging-guided Focal Laser Ablation of Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Urine incontinence incontinence
研究概览
简要总结
Magnetic resonance imaging-guided focal laser ablation of prostate cancer.
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
- 45 Years 至 76 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •MRI visible index lesion (on T2-weighted MR imaging or diffusion weighted imaging);
- •Maximum MRI visible lesion size is ≤ 15 mm large axis;
- •Life expectancy at inclusion of more 10 years;
- •Diagnosis of prostate cancer confirmed by targeted biopsy using TRUS-MRI fusion or in-bore MRI guided biopsies;
- •Criteria of low and intermediate risk of progression and eligibility for focal therapy (clinical stage of maximum T2c, maximum biopsy Gleason score of 4 + 3 on targeted biopsies, serum prostate specific antigen < 15 ng/ml);
- •Patient accepting to be included in an active surveillance protocol at the end of the study, in accordance with the recommendations of good practice.
排除标准
- •History of prostate surgery;
- •History of radiation therapy or pelvic trauma; history of proved acute or chronic prostatitis;
- •History of tumor in the preceding 5 years (excluded: non-metastatic basal cell skin cancer);
- •Severe urinary symptoms associated with benign hyperplasia of the prostate, and defined by an IPSS score > 18;
- •Tumor with MRI signs of extra-capsular extension or invasion of the seminal vesicles;
- •Maximum cancer core length >3 mm and/or maximum Gleason score of 3+4 on systematic biopsies outside the visible tumor area on mpMRI;
- •Impossibility to obtain a valid informed consent;
- •Patients unable to undergo MR imaging, including those with contra-indications;
- •Contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection);
- •Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging;
- •Patients with evidence for nodal or metastatic disease;
- •Patients with an estimated Glomerular Filtration Ratio (eGFR) < 40 mL/min/1.73 m2.
研究组 & 干预措施
Low or intermediate grade prostate cancer
Experimental
干预措施: Focal laser ablation (Procedure)
结局指标
主要结局
Urine incontinence incontinence
时间窗: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
To evaluate a change in the functional outcome urine incontinence before and after FLA in patients with localized low to intermediate risk prostate cancer (Gleason 3+3, 3+4 or Gleason 4+3).
次要结局
- Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF)(At inclusion, 3 months, 6 months, 12 months and 24 months follow up.)
- Complication rate(At inclusion , 3 months, 6 months, 12 months and 24 months follow up.)
- International Consultation on Incontinence Questionnaire (ICIQ)(At inclusion, 3 months, 6 months, 12 months and 24 months follow up.)
- Quality of life using a validated quality of life questionnaire (EORTC QLQ PR25(At inclusion , 3 months, 6 months, 12 months and 24 months follow up.)
- Local cancer control(At inclusion , 3 months, 6 months, 12 months and 24 months follow up.)
- International Prostate Symptom Score (IPSS)(At inclusion, 3 months, 6 months, 12 months and 24 months follow up.)
研究者
研究点 (1)
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