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MRI-guided transurethral ultrasound ablation in patients with localized prostate cancer - FOKATU-Pilot
niversitätsklinikum Dresden, Klinik und Poliklinik für Strahlentherapie und Radioonkologie0 个研究点目标入组 6 人开始时间: 2019年5月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 65 Years 至 80 Years（—）
- 性别
- Male
入选标准
- •locally limited unilateral, histologically confirmed prostate carcinoma
- •- male patients aged > 65 years < 80 years
- •- patients in good general condition (ECOG 0-1)
- •- histologically confirmed adenocarcinoma of the prostate (targeted MR-fused biopsy combined with systematic biopsy). Histologic confirmation should be > 6 weeks and < 4 months prior to the planned therapy and should be performed by MR-fused biopsy.
- •- localized unilateral prostate carcinoma with visible lesion in baseline MRI.
- •- maximum stage cT2a, Gleason 3+3=6 with maximum 4 affected cylinders or maximum stage cT2a with Gleason 3+4=7 with maximum 2 affected cylinders and maximum 50% of the punch cylinder surface affected.
- •- initial PSA value <15 ng/ml
- •- prostate volume < 90 ml
- •- general anesthetic ability (ASA category <3)
- •- MRI capability (see exclusion criteria)
- •- ability to consent and written consent of the patient
排除标准
- •- Bilateral infestation of the prostate gland
- •- capsule transgression, sphincter infiltration, seminal vesicle infiltration, lymph node infestation, metastases
- •- distance of tumor in baseline MRI more than 30 mm from urethra or within 3 mm around urethra, or in apex within 3 mm from sphincter
- •- Previous transurethral resections of the prostate (TURP-P) or other prostate surgical procedures
- •- Prostate calcifications (> 1 cm) within the sector to be treated (detected in TRUS, possibly in screening CT)
- •- Cysts on the prostate capsule within the area to be treated (baseline MRI)
- •- Clinically relevant prostatitis requiring treatment in the last 6 months prior to planned therapy
- •- Previous operations of the rectum or pelvis
- •- Chronic inflammatory bowel disease or other chronic diseases affecting the rectum, including fistulas and anal stenosis.
- •- Z.n. Radiotherapy of the pelvis
- •- Bladder or urethral dysfunction incl. urethralastricture, bladder diverticula, urethroplasty, fistulas etc.
- •- Patients with an artificial bladder sphincter or penis implant
- •- Severe neurogenic bladder dysfunction
- •- Symptomatic prostate hyperplasia with significant residual urine formation
- •- Untreated bladder stones
- •- Acute urinary retention within the last 12 months
- •- Acute untreated urinary tract infection
- •- Active untreated macrohaematuria
- •- Contraindications for MRT (cardiac pacemakers, defibrillators, non-mR-compatible endoprostheses, insulin pumps, grenade splinters, magnetic or electrically conductive implants, etc.)
- •- Contraindications for the insertion of a suprapubic bladder catheter: pre-surgery in the pelvis, scars in the area of the lower abdomen, vascular Y-prostheses, etc.
- •- Incompatibility/allergy to gadolinium (MRT contrast medium)
- •- Participation of the patient in another clinical trial if this requires further experimental therapy or if the therapies/study protocols are mutually exclusive.
- •- addiction or other illnesses which do not allow the person concerned to assess the nature and extent as well as possible consequences of the clinical trial
- •- Absence of written declaration of consent
研究者
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