NL-OMON48560招募中2 期
PRostatE Cancer MRI guided focal SalvagE high-dose-rate brachytherapy - PRECISE
niversitair Medisch Centrum Utrecht0 个研究点目标入组 88 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 88
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age >=18 years;
- •- Recurrence >=2 years after primary radiotherapy treatment (low-dose-rate
- •brachytherapy of external beam radiation therapy);
- •- Prostate Specific Antigen (PSA) at time of salvage <=20 ng/ml;
- •- Prostate Specific Antigen (PSA) doubling time >=9 months;
- •- Stage <=T3b tumor (extra prostatic extension into the seminal vesicle(s));
- •- Acceptable toxicity of primary radiation treatment (International Prostate
- •Symptom Score (IPSS)<15);
- •- Concordance between PSMA-PET/CT and mp-MRI;
- •- Tumor location technically feasible for brachytherapy;
- •- Karnofsky score >=70;
- •- Written informed consent;
- •- Fit for spinal anesthesia.
排除标准
- •- Distant metastases;
- •- Previous pelvic radiotherapy for another malignancy;
- •- Prior prostate treatment(s) like a recent transurethral resection of the
- •prostate (TURP) (<6 months before focal salvage HDR treatment), HIFU or
- •cryosurgery, except for radiotherapy;
- •- Contraindications for MRI;
- •- Severe toxicity from primary radiation treatment (IPSS >15);
- •- Anticoagulant administration continuously required, except for platelet
- •aggregation inhibitors (for example Ascal/Persantin).
研究者
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