High Dose Rate Partial Prostate Brachytherapy as Salvage Treatment for Local Failures After Previous External Beam Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Late adverse gastrointestinal or genitourinary events grade 3 or higher
研究概览
简要总结
A dose-response relationship for radiation in the management of prostate cancer is well established. Local recurrence of prostate cancer after external beam radiotherapy occurs in at least 40% of patients treated because of inability to deliver sufficient dose through external beam techniques. These patients respond well to re-irradiation using brachytherapy with about 50% of selected patients remaining free of recurrence 5 years after salvage. Advanced imaging using multiparametric Magnetic Resonance Imaging (mpMRI) allows identification of the site of recurrence, permitting partial prostate salvage brachytherapy. There is extensive literature on Low Dose Rate salvage brachytherapy but less on High Dose Rate.
详细描述
Appropriately selected patients with histologically documented recurrence 3 years or more after initial external beam radiotherapy will undergo mpMRI for identification of the site of recurrence. A planning transrectal ultrasound (TRUS) will be obtained for fusion with the mpMRI and transposition of the target volume (GTV=gross tumor volume). A margin of 4.5 cm will be added to the GTV to create a focal planning target volume (PTV). The margin may be cropped at the interface with critical organs. Two fractions of HDR brachytherapy will be delivered, each from a single implant, 2 weeks apart. Following treatment patients will be monitored for toxicity and quality of life using the Expanded Prostate cancer Index (EPIC) questionnaire as well as the International Prostate Symptom score. Efficacy will be evaluated by monitoring the Prostate Specific Antigen (PSA) and if PSA is rising during follow-up, PSMA PET will be ordered when clinically indicated..
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age >45 and Life expectancy >10 years
- •Previous External Beam Radiotherapy (EBRT) or LDR brachytherapy w
- •> 3 year interval since EBRT or LDR Brachytherapy
- •No late toxicity from prior EBRT ≥ grade 2
- •PSA > nadir + 2 ng/ml and < 10 ng/ml
- •PSA Doubling time > 6 months
- •Radiographic evidence corresponding with site of recurrence in an under-dosed or untreated site. The recurrence should correspond to the site of original disease or be located in the seminal vesical +/- adjacent prostate as only area of recurrence (i.e. unifocal recurrence).
- •Per Investigator, recurrence is suitable for implant with HDR brachytherapy and patient is suitable for procedure under anesthesia, spinal or general.
- •Negative staging of the abdomen/pelvis and bones.
- •Willing to provide informed consent
排除标准
- •Not compliant with criteria above
- •Unable to give informed consent
研究组 & 干预措施
HDR partial prostate brachytherapy
2 fractions of high dose rate prostate brachytherapy will be delivered to the site of recurrent disease as determined by mp-MRI
干预措施: HDR partial prostate brachytherapy (Radiation)
结局指标
主要结局
Late adverse gastrointestinal or genitourinary events grade 3 or higher
时间窗: 3-60 months
Common Terminology Criteria for Adverse Events (CTCAE V4.0)
次要结局
- Late Quality of Life(3-60 months)
- Late lower urinary tract symptoms(3-60 months)
- Acute grade 3 or higher gastrointestinal or genitourinary adverse events(0-3 months)
- Acute Quality of Life changes(0-3 months)
- Acute lower urinary symptoms(0-3 months)
- Biochemical disease free survival(60 months)
- Number of participants with site of failure determined by PSMA PET Scan at the time of rising PSA.(2 years)
- Number of participants with site of recurrence on mpMRI improved from PiRADS 4 or 5 to PiRADS 3 or less.(2 years)
研究者
Juanita Crook
Professor of Radiation Oncology
British Columbia Cancer Agency