Magnetic Resonance (MR)-US Fusion Biopsy-Guided Focal Bipolar Radio-Frequency Ablation of the Prostate in Men With Localized Prostate Cancer (FUSAblate Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of Subjects Resulting in Negative Biopsy as a Measure of Efficacy
研究概览
简要总结
This is a prospective single center trial to examine the rate of negative biopsy result and quality of life after focal ablation by radiofrequency energy. The primary evaluation involves assessing the rate of negative biopsy result using MR-US fusion biopsy six months after focal ablation of the prostate. Urinary and sexual quality of life will be assessed through validated measures. The hypothesis of our study is that focal ablative therapy will result in a greater likelihood of negative biopsy on followup biopsy than that observed in men who elect not to undergo therapy.
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
- •Subject Population:
- •Men 40-80 years of age
- •Diagnosis of adenocarcinoma of the prostate, confirmed by TransRectal Ultrasound (TRUS) biopsy
- •No prior treatment for prostate cancer
- •Prostate Cancer Clinical Stage T1c
- •Prostate-specific antigen (PSA)<10 ng/ml (this will be the PSA level prompting the initial prostate biopsy)
- •Declined all standard treatment options
- •Pre-enrollment biopsy parameters:
- •Minimum of 12 biopsy cores
- •Gleason 6 (3+3) or 7 (3+4)
- •Final enrollment biopsy parameters after fusion biopsy:
- •12 standard biopsy cores plus targeted regions based upon MRI
- •Gleason 6 (3+3) or 7 (3+4)
- •No demonstrated cancer diameter >1.2 cm
排除标准
- •Histology other than adenocarcinoma
- •Biopsy does not meet inclusion criteria
- •History of transurethral resection of prostate (TURP) or other similar procedures transurethral microwave therapy (TUMT), transurethral needle ablation (TUNA)
- •History of prior pelvic radiation
- •Men who have received any hormonal manipulation (antiandrogens; luteinizing hormone-releasing hormone (LHRH)-agonist; 5-alpha-reductase inhibitors) within the previous 12 months
- •Contraindication for Multiparametric-MRI
研究组 & 干预措施
Bipolar Radiofrequency Focal Ablation
Men identified as having suspicious regions on an Prostatic multi-parametric MRI (mpMRI) of the prostate will be considered for enrollment. If followed by a positive MRI-US targeted biopsy of the prostate, men who be offered enrollment into the study. All men enrolled in the study will undergo bipolar radiofrequency ablation. Efficacy will be assessed through MRI-US biopsy after focal bipolar RFA.
干预措施: Bipolar Radiofrequency Focal Ablation (Procedure)
结局指标
主要结局
Number of Subjects Resulting in Negative Biopsy as a Measure of Efficacy
时间窗: 6 months after focal bipolar radiofrequency ablation (RFA)
The primary endpoint of the trial will be assessed at 6 months after focal bipolar RFA by repeat mp-MRI imaging and fusion biopsy. Treatment efficacy, defined as a negative, will be determined by the results of the MRI-US targeted biopsy that will include regions treated by focal bipolar RFA.
次要结局
- Expanded Prostate Cancer Index Composite (EPIC) Score to Measure Quality of Life Post Focal Ablation(1 week; 2 week; 1 month; 3 months; 6 months)
- Short Form - 12 (SF-12) to Measure Quality of Life Post Focal Ablation(1 week; 2 week; 1 month; 3 months; 6 months)
- International Prostate Symptom Score to Measure Quality of Life Post Focal Ablation(1 week; 2 week; 1 month; 3 months; 6 months)
- International Index of Erectile Function questionnaires Score (IEFF) to Measure Quality of Life Post Focal Ablation(1 week; 2 week; 1 month; 3 months; 6 months)