An evaluation of Focal ablation therapy using High-Intensity Focused Ultrasound in the treatment of localised adenocarcinoma of the prostate

niversity College London Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 42 人开始时间: 2008年7月3日最近更新: 2022年11月7日

适应症

试验速览

暂无简介。

•1. Men aged 45 - 80 years
•2. Histological diagnosis of prostate adenocarcinoma
•3. Gleason grade total 7 or less (patterns 3+4 or 4+3 or less acceptable)
•4. Cancer prostate-confined only (bilateral or unilateral)
•5. Serum prostate specific antigen (PSA) less than or equal to 15 ng/mL
•6. A life expectancy of 5 years or more
•7. Prostate volume less than or equal to 40 cc or maximum anterior-posterior length less than or equal to 40 mm
•8. Has had multi-sequence magnetic resonance imaging (ms-MRI) and transperineal template 5 mm spaced biopsies in the 6 months prior to recruitment
•9. All malignant areas are treatable by focal ablation so that approximately 50% of prostate tissue is destroyed and at least one neurovascular bundle is preserved
•10. Signed informed consent form by patient

•1. Men who have received androgen suppression within previous 6 months
•2. Men who have had previous radiation therapy for prostate cancer
•3. Men treated with chemotherapy for prostate cancer
•4. Men with evidence of metastatic disease
•5. Men with latex allergies
•6. Men who have undergone prior significant rectal surgery preventing insertion of transrectal probe
•7. Men with intraprostatic calcifications making HIFU of focal areas of cancer untreatable
•8. Men who have undergone previous transurethral resection of the prostate or laser prostatectomy in the 5 years prior to recruitment
•9. Men who have undergone previous HIFU, cryosurgery, thermal or microwave therapy to the prostate at any point prior to recruitment
•10. American Society of Anaesthesiology grades III - IV
•11. Men not fit for general anaesthesia or regional anaesthesia as assessed by Consultant Anaesthetist
•12. Men unable to have MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, metallic implant likely to contribute significant artifact to images)

发起方

niversity College London Hospitals NHS Foundation Trust (UK)