NL-OMON20394招募中不适用
PRostatE Cancer MRI guided focal SalvagE high-dose-rate brachytherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
研究概览
简要总结
one
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Age >18 years;
- •- Recurrence >2 years after primary radiotherapy treatment (LDR-BT or EBRT);
- •- PSA at time of salvage <20 ng/ml;
- •- PSA doubling time >9 months;
- •- Maximum stage T3b tumor (extra prostatic extension into the seminal vesicle(s));
- •- Acceptable toxicity of primary radiation treatment (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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