Randomised controlled trial of brachytherapy versus radical prostatectomy in good risk prostate cancer: a feasibility study

Southampton University Hospitals NHS Trust (UK)0 个研究点目标入组 400 人开始时间: 2008年5月16日最近更新: 2020年3月3日

适应症

试验速览

•1. Suspected prostate cancer that is confined to the prostate
•2. Due for prostate biopsy
•3. World Health Organisation performance status 0 - 1
•4. Prostate-Specific Antigen (PSA) less than 15 ng/ml
•5. Life expectancy more than 10 years
•6. Written informed consent
•Inclusion criteria for treatment randomisation:
•1. Participation in decision aid randomisation
•2. Histologically confirmed prostate cancer
•3. Clinical T stage T1/T2
•4. Either Gleason score less than or equal to 6 with a PSA of less than 15 or Gleason score 3 + 4 in less than 50% of the cores with a PSA less than 10 (PSA test less than 3 months prior to treatment intervention)

•1. Unacceptable risk for radical prostatectomy
•2. Unacceptable risk for brachytherapy
•3. Prior pelvic radiotherapy
•4. Other active malignancy likely to interfere with subsequent protocol treatment and follow-up
•5. Previous abdominoperineal (AP) rectal excision
•6. Previous transurethral resection of their prostate gland (TURP)
•7. Significant obstructive urinary symptoms (peak urine flow rate less than 10 ml per second, post micturition bladder volume greater than 75 ml)
•8. Severe lower urinary tract symptoms
•9. Inability to attend or comply with treatment or follow-up scheduling

发起方

Southampton University Hospitals NHS Trust (UK)