NL-OMON50019招募中2 期
EREctile Conservation after prostate radiation Therapy (ERECT); a prospective phase 2 trial - ERECTtrial
niversitair Medisch Centrum Utrecht0 个研究点目标入组 70 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
- 70
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
- •Histologically proven adenocarcinoma of the prostate
- •Low-risk or intermediate-risk prostate cancer according to NCCN risk
- •categories (low risk: T1c-T2a, Gleason score <=6, and PSA <10 µg/L; intermediate
- •risk: T2b-T2c or Gleason score 7 or PSA 10-20 µg/L)
- •Patients with pT1a/b tumor diagnosis after transurethral resection of the
- •prostate (TURP)
- •Domain score of 17-25 on the International Index of Erectile Function-5
- •(IIEF-5) questionnaire
- •Karnofsky score of 70-100
- •Written informed consent
排除标准
- •Use of (neo-)adjuvant androgen deprivation therapy
- •High-risk prostate cancer according to NCCN risk categories (T3a or Gleason
- •score 8-10 or PSA >20 µg/L)
- •Patients with *bulky* iT3 tumor diagnosis
- •Previous pelvic irradiation or radical prostatectomy
- •Clinical evidence of metastatic disease
- •Patients who meet exclusion criteria for MRI following the protocol of the
- •radiology department of the UMC Utrecht (see appendix I)
- •Patients who are incompetent to sign written informed consent
研究者
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