Pilot Study of Intra-Urethral Radiotransponder Beacon Guided Focal Prostate Stereotactic Body Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Confirm the Feasibility of Focal Prostate Stereotactic Body Radiotherapy (SBRT) With Real Time Guidance by Intra-urethral Radiotransponder Beacons.
研究概览
简要总结
This study offers focal therapy for prostate cancer by using an intra-urethral radiotransponder temporarily placed during radiotherapy. The study aims to improve the risk-benefit ratio of therapy for early prostate cancer and potentially lessen symptom burden over time.
详细描述
This study offers focal stereotactic body radiotherapy for prostate cancer by using an intra-urethral radiotransponder placed temporarily during each of the 5 radiotherapy treatments. The study aims to improve the risk-benefit ratio of therapy for early prostate cancer and potentially lessen symptom burden over time while also accessing early efficacy, late toxicity, and overall quality of life post-treatment. Patients will be followed for 24 months (2 years) with follow-up appointments at 3, 6, 9, 12, 18, and 24 months.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All patients must have histologically confirmed adenocarcinoma of the prostate, with biopsies obtained within 12 months of registration
- •Gleason score 3+3 or 3+4
- •PSA <10 ng/mL within 3 months of enrollment
- •Clinical stage T1a-T2a by digital rectal exam
- •Up to 2 intraprostatic nodules visible on MRI, with combined volume <50% of the total prostate volume
- •Karnofsky Performance Status (KPS) >70%.
- •Life expectancy >10 years
- •Age ≥ 19 years
- •Subjects given written informed consent
排除标准
- •>2 MRI defined nodules representing prostate cancer
- •Total volume of MRI nodules exceeding 50% of total prostate volume
- •Positive biopsy core in sextant region without MRI defined nodule (i.e. biopsy proven MRI occult prostate cancer)
- •American Urological Association (AUA) urinary score ≥
- •History of inflammatory bowel disease.
- •Prior pelvic surgery
- •Prior treatment for prostate cancer
- •Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids is not considered an exclusion criteria.
- •Platelet count < 70,000/µL
- •Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria.
- •Contraindication to MRI such as implanted devices.
- •Metallic pelvic implants resulting in imaging artifact within the prostate on MRI or CT
结局指标
主要结局
Confirm the Feasibility of Focal Prostate Stereotactic Body Radiotherapy (SBRT) With Real Time Guidance by Intra-urethral Radiotransponder Beacons.
时间窗: 2 years
Confirm the technical feasibility of using focal prostate stereotactic body radiotherapy (SBRT) instead of traditional treatment methods using a 16-french Foley catheter and real time guidance by intra-urethral radiotransponder beacons.Feasibility will be defined as the ability of the treatment to take place as planned.
次要结局
- Assess Late Toxicity(Within 6 months of completion of radiation therapy)
- Assess Early Efficacy(Within 6 months of completion of radiation therapy)
- Assess Quality of Life(Within 6 months of completion of radiation therapy)
研究者
Andrew McDonald
Assistant Professor - Department of Radiation Oncology
University of Alabama at Birmingham