PRAMA (Prostate Resection After Microwave Ablation) MRI/Ultrasound Fusion Guided Transperineal Targeted Microwave Ablation for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- The Area of the Transperineal Targeted Microwave Ablation (TMA) Induced Tissue Death Assessed by Triphenyltetrazolium Chloride (TTC) Staining
研究概览
简要总结
This phase I trial tests the safety of magnetic resonance imaging (MRI)/ ultrasound (US) fusion guided transperineal targeted microwave ablation (TMA) before a radical prostatectomy (RP) and how well it works in treating patients with prostate cancer. Prostate cancer is the second most common cancer in men and most will never become aggressive. Despite this, most men choose to undergo treatment which may include surgery. Removing the prostate gland and sometimes the lymph nodes (radical prostatectomy) is an invasive treatment for prostate cancer that can have a significant negative on quality of life. TMA is a less invasive procedure that uses high temperatures given through the skin between the scrotum and the rectum (transperineal). Using focused high energy and heating tumor cells to several degrees above normal body temperature may kill them without affecting the surrounding tissue. Using multiparametric (mp)MRI/US to create a 3-dimensional picture of the tumor may help in planning and preventing damage to healthy tissue. Giving MRI/US fusion guided transperineal TMA prior to radical prostatectomy may kill tumor cells, and may improve the quality of life in patients with prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. To determine the feasibility of transperineal targeted microwave ablation of an MRI-identified index prostate cancer in patients undergoing radical prostatectomy.
SECONDARY OBJECTIVES:
I. KOELIS Trinity ability to plan and guide treatment needles and ablations in the prostate index lesion.
II. Impact of treatments on functional outcomes and quality of life. III. Predictability of Medwaves Avecure microwave ablation charts. IV. Predictability of post microwave ablation 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult men diagnosed with prostate cancer and undergoing prostatectomy as treatment of choice
- •Index lesion visible on multiparametric MRI confirmed by targeted biopsies using KOELIS Trinity (registered trademark)
- •Patient suitable for intravenous (IV) sedation or general anesthesia and TMA
- •Free, informed, and written consent, dated and signed before the enrollment and before any exam required by the trial
排除标准
- •Past medical history of prostate surgery
- •Past medical history of radiotherapy or pelvic trauma
- •Past treatment for prostate cancer (PCa) (radiation, ablation, androgen deprivation therapy [ADT], chemotherapy)
结局指标
主要结局
The Area of the Transperineal Targeted Microwave Ablation (TMA) Induced Tissue Death Assessed by Triphenyltetrazolium Chloride (TTC) Staining
时间窗: At time of radical prostatectomy (RP) immediately after TMA
The excised prostate will be sliced at 4 mm intervals. Each slice will be embedded, and a pathologist will examine the slides corresponding to each slice. The pathologist will be blinded to MR and ultrasound imaging results. TTC staining is performed to determine the dead tissue induced by the TMA.
次要结局
- Number of Microwave Ablations Needed to Ablate One Multiparametric Magnetic Resonance Imaging (mpMRI)-Visible Lesion(At time of TMA)
- Incidence of Adverse Events(Up to 30 days after RP)
- Duration of Targeted Microwave Ablation (TMA) Procedure(At completion of TMA)
- The Area of the Transperineal Targeted Microwave Ablation (TMA) Induced Tissue Death Assessed by Hematoxylin and Eosin (H&E) Staining.(At time of RP, 30 days after TMA)
- Difference Between the Ablation Location in the Prostate as Seen in the KOELIS 3-dimensional Map and the Ablation Location Observed Histologically on the Prostatectomy Specimen(Up to 1 month)
- Change in Urinary Functions Assessed by International Prostate Symptoms Score and Uroflowmetry(At baseline and each follow up visit, up to 30 days after RP)
- Difference Between the Treatment Effect Dimensions Measured Histologically on the Prostatectomy Specimen Resected One Month After TMA, Compared to Post TMA Dimensions Measured on the Pre-RP mpMRI(At time of RP, 30 days after TMA)
- Change in Erectile Functions Assessed by International Index of Erectile Function-5 Score(At baseline and each follow up visit, up to 30 days after RP)
- Change in Quality of Life Assessed by Expanded Prostate Cancer Index Composite-26 Short Form(At baseline and each follow up visit, up to 30 days after RP)
- Difference Between the Treatment Effect Dimensions Measured Histologically on the Prostatectomy Specimen Resected After TMA, Compared to the Predictive Ablation Charts Provided by the Manufacturer(Day after the TMA procedure)