ISRCTN99760303已完成Unknown
A randomised controlled trial of Partial prostate Ablation versus Radical prosTatectomy (PART) in intermediate risk unilateral clinically localised prostate cancer - a feasibility study
niversity of Oxford (UK)0 个研究点目标入组 80 人开始时间: 2014年10月6日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30264692 results
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •Current inclusion criteria as of 11/02/2016:
- •1. Men with unilateral clinically significant intermediate risk prostate cancer or dominant unilateral clinically significant intermediate risk & small contralateral low-risk disease:
- •1.1. Gleason grade score 7 (3+4 or 4+3)
- •1.2. High volume Gleason grade score 6 (> 4mm cancer core length)
- •1.3. PSA = 20 ng/ml
- •1.4. Clinical = T2b disease
- •2. Life expectancy of =10 years
- •3. Fit, eligible and normally destined for radical surgery
- •4. No concomitant cancer
- •5. No previous treatment of their prostate cancer
- •6. An understanding of the English language sufficient to understand written and verbal information about the trial, its consent process and the study questionnaires
- •Previous inclusion criteria:
- •1. Men with unilateral clinically significant intermediate risk prostate cancer:
- •1.1. Gleason grade score 7 (3+4 or 4+3)
- •1.2. And/or > 4mm cancer core length
- •1.3. PSA = 20 ng/ml
- •1.4. - = T2b disease
- •2. Fit and eligible for radical surgery
- •3. No concomitant cancer
- •4. No previous treatment of their prostate cancer
排除标准
- •Current exclusion criteria as of 11/02/2016:
- •1. Unfit for radical surgery
- •2. Significant bilateral disease
- •3. Low risk disease [Gleason score 6 or less, PSA 10ng/ml]
- •4. High risk disease [Gleason score 8 or greater, PSA >20ng/ml]
- •5. Clinical T3 disease
- •6. Men who have received previous active therapy for prostate cancer
- •7. Men with evidence of extra prostate disease
- •8. Men with an inability to tolerate a transrectal ultrasound
- •9. Men with latex allergy
- •10. Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months.
- •11. Metal implants/stents in the urethra
- •12. Prostatic calcification and cysts which interfere with effective delivery of HIFU
- •13. Men with renal impairment and a GFR <35ml/min
- •14. Unable to give consent to participate in the trial as judged by the attending clinicians
- •Previous exclusion criteria:
- •1. Unfit for radical surgery as assessed by Consultant Anaesthetist
- •2. Significant bilateral disease
- •3. Low risk disease [Gleason score 6 or less, PSA 10ng/ml or less, less than 4mm total cancer on biopsy]
- •4. High risk disease [Gleason score 8 or greater, PSA >20ng/ml, T2c stage or higher]
- •5. Men who have had previous radiation therapy
- •6. Men who have had androgen suppression/hormone treatment within the previous 12 months for their prostate cancer
- •7. Men who have had previous HIFU, cryosurgery, thermal or microwave therapy to the prostate.
- •8. Men with evidence of metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging
- •9. Men with an inability to tolerate a transrectal ultrasound or men with latex allergies as the HIFU probe is covered with a latex condom sheath prior to insertion into the back passage
- •10. Men who have undergone prior significant rectal surgery preventing insertion of trans-rectal HIFU probe (decided on the type of surgery in individual cases)
- •11. Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months. These patients may be included within the trial if deferred from consenting and screening until at least 6 months following the TURP.
- •12. Presence of metal implants/stents in the urethra
- •13. Presence of prostatic calcification and cysts (on transrectal ultrasound) whose location will interfere with effective delivery of HIFU therapy
- •14. Men with renal impairment with a GFR of <35ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI)
- •15. Unable to provide informed consent (eg because of cognitive impairment)
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