Prospective Multi-centre Study of Low-dose Rate Iodine125 (I-125) Prostate Brachytherapy Performed After Transurethral Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in acute and late urinary toxicity defined by International Prostate Specific Score and Common Terminology Criteria for Adverse Events v4.
研究概览
简要总结
Low dose rate brachytherapy using iodine 125 is well established as a treatment for low and intermediate risk prostate cancer. Currently there is uncertainty as to the safety of this technique in patients who have had a previous transurethral resection of the prostate gland (TURP) for obstruction of the urine flow through the prostatic urethra. Early experience when the technique was being developed in the 1980s suggested that there was a higher incidence of urinary incontinence after brachytherapy if there had been a previous TURP. It is however clear that with increasing experience many centres offer this treatment to patients who have had previous TURP, using various parameters to select patients including time from the TURP and persence or absence of a significant cavity within the gland on MRI scanning. There has been no systematic study of I125 brachytherapy after TURP in the current era which might address and inform the practice for future patient. Hence this study is designed to formally assess the safety of I125 brachytherapy after previous TURP.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •WHO performance status 0-1
- •No contra-indication for anaesthesia
- •No history of irradiation of the pelvis
- •No other oncologic malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient is disease free for at least 5 years.
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
- •Prostate (cancer) related:
- •Histologically proven prostate cancer (adenocarcinoma) of low or intermediate risk following the D'Amico classification.
- •Prostate volume < 50 cc as measured on transrectal ultrasound
- •Neo-adjuvant antiandrogen hormonal treatment is permitted to downsize the prostate volume or to cover waiting time till brachytherapy procedure. No adjuvant hormonal treatment is permitted.
- •History of TransUrethral Resection of the prostate (TURp), performed at least 3 months before the brachytherapy procedure.
- •Rim of prostate tissue of at least 1 cm around the post-TURp urethral defect at thepostero-lateral sides of the prostate
- •Absence of significant TURp-induced urinary incontinence
- •IPSS <15
排除标准
- •Locally advanced (stage T3 or T4 , or metastatic (stage N+ or M+) prostate cancer High grade tumours defined by Gleason score 8 or above Co-morbidity which would exclude the patient from a transperineal implant procedure.
- •Unable to give informed consent.
结局指标
主要结局
Change in acute and late urinary toxicity defined by International Prostate Specific Score and Common Terminology Criteria for Adverse Events v4.
时间窗: Measured at 1 mth, 3 months, 6 month, 12 months, 18 months, 24 months and then yearly
This change will be measured at 1 mth, 3 months, 6 month, 12 months, 18 months, 24 months and then yearly
次要结局
- Gastro-intestinal and sexual function(Measured at 12 mth.)