ISRCTN17249875进行中（未招募）未知
A randomised controlled trial of Partial prostate Ablation versus Radical Treatment (PART) in intermediate risk, unilateral clinically localised prostate cancer
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 800
研究概览
简要总结
暂无简介。
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 18/11/2022:
- •1. Age =18 years with unilateral clinically significant intermediate-risk Gleason Grade Group 2 or 3 (3+4 or 4+3) PCa, or dominant unilateral clinically significant intermediate-risk PCa and contralateral low-risk low-volume Gleason Grade Group 1 (3+3) PCa:
- •2. PSA = 20 ng/ml within the last 90 days
- •3. Pre-biopsy mpMRI scan and bilateral biopsies of the prostate (transrectal or transperineal, and targeted biopsy for visible lesions)
- •4. Clinically =T2b disease judged by results of digital rectal examination, imaging by Multi-parametric Magnetic Resonance Imaging (mpMRI) and biopsy (low-risk Gleason Grade Group 1 lesions on the contralateral side are acceptable)
- •5. Fit, eligible with a standard of care recommendation for any or all of radical prostatectomy, radical radiotherapy or low dose-rate brachytherapy (LDR-B), and suitable for PA using at least one of irreversible electroporation (IRE) or high intensity focused ultrasound (HIFU)
- •6. An understanding of the English language sufficient to receive written and verbal information about the study, its consent process and complete study questionnaires
- •Previous inclusion criteria:
- •1. Unilateral clinically significant intermediate-risk prostate cancer, or dominant unilateral clinically significant intermediate-risk prostate cancer and small contralateral low-risk low-volume prostate cancer:
- •1.1. Grade Group 2 or 3 (Gleason Grade 3+4 or 4+3) disease
- •1.2. And/or >4 mm cancer core length in any one core irrespective of Grade Group
- •1.3. PSA =20 ng/ml
- •1.4. Clinically =T2b disease judged by results of digital rectal examination and imaging by mpMRI
- •2. Prostate volume <70 cm3 and =25 cm3
- •3. Fit, eligible with standard of care recommendation for RP, RRT or LDR-B
- •4. Life expectancy of =10 years
- •5. No concomitant cancer and no previous active treatment for prostate cancer
- •6. Pre-biopsy mpMRI scan and biopsy (transrectal targeted guided by presence of PIRADS lesions +/- systematic biopsy, or template transperineal mapping biopsy)
- •7. Understanding of the English language sufficient to receive written and verbal information about the trial, its consent process and complete study questionnaires
排除标准
- •Current exclusion criteria as of 18/11/2022:
- •1. Taking part in another therapeutic PCa clinical trial or has been involved in such trials within the previous 4 months (N.B. the TRANSLATE trial is a diagnostic trial and co-enrolment is permitted)
- •2. PSA > 20 ng/ml within the last 90 days
- •3. Unfit for radical treatment or general anaesthesia or cannot tolerate transrectal ultrasound
- •4. In the opinion of the treating physician, has a contraindication to either HIFU or IRE
- •5. Not suitable for mpMRI or have a single or bilateral hip replacement
- •6. Has evidence of extraprostatic extension by mpMRI, or clinical or radiological =T3 disease
- •7. Concomitant cancer or previous active treatment for PCa
- •8. Evidence of metastatic disease
- •9. Bilateral intermediate risk disease or higher
- •10. Low-risk (Gleason Grade Group 1) disease only, or high-risk (Grade Group =4) PCa only
- •11. History of acute urinary retention within the last 6 months prior to entry to the study
- •12. Prostatic calcification and cysts causing ultrasonic shadowing or greater than 1cm (for HIFU)
- •13. History (within 3 years) of inflammatory bowel disease or any condition that may increase the risk of recto-urethral fistula formation (for HIFU)
- •14. Has known hypersensitivity to pancuronium bromide, atracurium or cistracurium, or any medical condition such that muscle relaxation cannot be administered as part of a general anaesthetic
- •15. Has a history of bladder neck contracture
- •16. Had active treatment for a malignancy within 3 years, including malignant melanoma, except other types of skin cancer
- •17. Has any active implanted electronic device (e.g., pacemaker)
- •18. Is unable or unwilling to be catheterised
- •19. Has had prior or current PCa therapies
- •20. Has had prior transurethral prostatectomy (TURP), stricture surgery, urethral stent or prostatic implants
- •21. Has had prior major rectal surgery (except haemorrhoids)
- •22. Is actively bleeding, is anticoagulated or on blood thinning medications that cannot be stopped for the peri-operative period for a PA procedure, or has a significant bleeding disorder that may affect the peri-operative period as judged by the clinical staff.
- •23. Unable to give consent to participate in the study as judged by the clinical staff
- •24. Wishing to maintain future fertility
- •Previous exclusion criteria:
- •1. Unfit for radical treatment or general anaesthesia, or cannot tolerate transrectal ultrasound
- •2. Bilateral Intermediate risk disease or higher
- •3. Low-risk disease (Grade Group 1, PSA =10 ng/ml, <4 mm total cancer on biopsy) or high-risk disease (Grade Group =4, PSA >20 ng/ml, =T2c stage)
- •4. Clinical T3 prostate cancer (i.e. extra-capsular prostate cancer) on digital rectal examination or mpMRI, or evidence of metastatic disease
- •5. Prostate volume =70 cm3 or <25 cm3
- •6. Previous active therapy for prostate cancer
- •7. History of sun hypersensitivity or photosensitive dermatitis or latex allergy
- •8. History of acute urinary retention within 6 months of study entry or who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms, or with metal implants/stents in the urethra, or with a history of a urethral stricture
- •9. Conditions requiring medication with potential photosensitizing effects (tetracyclines, quinolones, sulphonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin, and amiodarone), if these treatments could not be stopped at least 10 days before and for 3
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