Prospective Multicenter Trial Assessing the Efficacy of a Novel 3D Cartography-based Targeted Focal Microwave Therapy in Men With Localized Intermediate-risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Koelis
- 入组人数
- 76
- 试验地点
- 5
- 主要终点
- The proportion of patients with no evidence of cancer on targeted biopsy
研究概览
简要总结
Multicenter, prospective, European, single-arm, open-label, 12-month follow-up clinical trial. The purpose of this study is to evaluate the efficacy of a 3D cartography-based targeted microwave ablation for the treatment of the index lesion in patients with intermediate risk prostate cancer.
详细描述
European and American guidelines recommend several therapeutic alternatives: radical surgical treatment, external beam radiotherapy or brachytherapy. However, whole-gland treatment induces significant morbidity and burden on quality of life. Targeted treatments of the index tumor are currently under investigation to decrease morbidity while proposing active treatment.
The purpose of this study is to assess the efficacy of a novel ablation treatment using microwaves, delivered transrectally or transperineally under real-time guidance with MRI-transrectal ultrasound image registration. The index tumor will be detected with prostate MRI and characterized with targeted biopsies using Organ Based Tracking (OBT) fusion with the TRINITY system (KOELIS, Meylan, France). The same system will be used to identify the index lesion and guide the targeted microwave ablation performed with the TATO3 device (Biomedical Srl, Florence, Italy).
All patients will undergo biopsy at 12 months of follow-up. A biopsy session will also be performed at 6 months, but only for patients with imaging results suspicious for cancer within the ablated area on the mpMRI.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient aged from 45 to 80 years old
- •Life expectancy >10 years at the inclusion time
- •Patient diagnosed with an intermediate-risk prostate cancer, defined by:
- •A T1c or T2a clinical stage
- •A unique cancer focus of Gleason (3+4) (Grade Group 2). In addition to the index lesion intended for treatment, the presence of additional microfoci < 10mm on mpMRI, for which biopsies present no evidence of cancer or a Gleason score of 3+3, is accepted
- •A PSA level <20 ng/mL
- •Cancer focus identified on a multiparametric MRI of the prostate no more than 3 months before inclusion
- •Confirmation of the suspicion of cancer identified on the MRI with transrectal or transperineal targeted and systematic biopsies performed with the KOELIS TRINITY system (no more than 3 months before inclusion)
- •Patient suitable for IV sedation or general anesthesia and focal microwave ablation
- •No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
- •Known coagulopathy or bleeding disorders are controlled
- •Free, informed and written consent, dated and signed before the enrollment and before any exam required by the trial
- •Patient affiliated to social security regimen or beneficiary of such regimen for local regions
排除标准
- •Past medical history of prostate surgery
- •Past medical history of radiotherapy or pelvic trauma
- •Past medical history of acute prostatitis
- •Presently taking hormonal manipulation or androgen supplements.
- •Past medical history of cancer in the 5 previous years, excluding a non-metastatic basal cell carcinoma of the skin
- •Severe BPH-related urinary tract symptoms, defined by an IPSS score >18
- •Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit
- •Contraindications for MRI exam
- •Extracapsular cancer extension or seminal vesicles or pelvic lymph node invasion suspected on prostate MRI
- •Presence of two or more clinically significant cancer foci in the inclusion biopsy exam
- •Presence of a clinically significant cancer with a Gleason score ≥8 (Grade Group ≥4)
- •Tumor largest axis >15 mm on the prostate MRI
- •Distance between the cancer focus and the apex <5 mm on the prostate MRI
- •Distance between the cancer focus and the rectum <5 mm on the prostate MRI
- •Patient already participating in an interventional clinical trial
- •Patient protected by law
研究组 & 干预措施
Targeted microwave ablation
Targeted microwave transrectal or transperineal ablation of the prostatic index tumor using MRI-transrectal image registration and OBT fusion
干预措施: Targeted microwave ablation (Device)
结局指标
主要结局
The proportion of patients with no evidence of cancer on targeted biopsy
时间窗: 12 months
The proportion of patients with no evidence of cancer on targeted biopsy at 12 months, defined by a minimum of 2 targeted core biopsies taken from the index tumor site treated with microwave ablation for focal treatment of intermediate risk prostate cancer
次要结局
- Surgeon opinion regarding adequate guidance of the microwave ablation needle(Day 1)
- Adequate guidance of the microwave ablation needle on the treated index lesion(Day 1)
- Adequate guidance of the microwave ablation needle on the treated index lesion and margins(Day 1)
- Learning curve of the TMA procedure(Day 1)
- Proportion of radical salvage treatment(12 months)
- Time to radical salvage treatment(12 months)
- Proportion of patients with any cancer in the untreated area(12 months)
- Proportion of patients undergoing treatment for cancer in the untreated area(12 months)
- IPSS questionnaire(7 days and 1, 6 and 12 months)
- IIEF-5 questionnaire(7 days and 1, 6 and 12 months)
- MSHQ-EjD-SF questionnaire(7 days and 1, 6 and 12 months)
- Urine flow(7 days and 1, 6 and 12 months)
- Adverse events(12 months)
- Patient post-operative pain level(Treatment day-evaluated between 2 and 4 hours after the procedure)
- Patient satisfaction(1, 6 and 12 months)
- Ease of the procedure(Day 1)
- PSA(1, 3, 6, 9 and 12 months)
- PSA Nadir(12 months)
- Duration of the procedure and associated variables(Day 1)
- Prostate volume(7 days and 6 and 12 months)
- Patient motivation(Baseline)