JPRN-jRCTs031180252已完成3 期
RCT of Tri-Modalities with I-125 Brachy Therapy and EBRT and Short or Long Term Hormone Therapy for High-risk Localized Prostate Cancer - TRIP STUDY
AMIKI Mikio0 个研究点目标入组 349 人开始时间: 2019年3月13日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 349
研究概览
简要总结
TRIP trial was designed to determine whether long-term ADT was superior to short-term ADT when combined with brachytherapy and EBRT for localized high-risk prostate cancer. Primary endpoint was PSA progression-free survival (PFS). Secondary endpoints were OS, clinical PFS, disease-specific survival, salvage treatment FS, metastasis FS, and evaluation of QOL and voiding function. There were no significant differences between the two arms in any of the endpoints.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 40age old 至 <= 80age old（—）
- 性别
- Male
入选标准
- •1) Patients with high risk prostate cancer which is defined by PSA value, clinical stage or Gleason score determined by the central pathological judgment.
- •High risk is the case where at least one of the following three factors is satisfied
- •(1) PAS>20 ng/mL prior to CAB
- •(2) Clinical stage of T2c or T3a
- •(3) GS>=8 by central pathologists
- •2) Performance status 0-1 (ECOG)
- •3) Age>=40 and <80 when obtaining the written informed consent
- •4) Patients who satisfy the following (within 14 days prior to the CAB)
- •a) Peripheral blood test : WBC>=3.0x103/microL, hemoglobin>=10.0 g/dL, blood plate>=10x104/microL
- •b) Biological test: serum creatinine<=2.0 mg/dL, AST(GOT)<=100 IU/L, ALT(GPT)<=100 IU/L
- •5) Written informed consent must be obtained from patient
排除标准
- •1) Patients who have active double cancer
- •2) Patients with poorly controlled hypertension (i.e., diastolic blood pressure>=120 mm Hg)
- •3) Patients with severe psychiatric disorders
- •4) Patients with collagen diseases
- •5) Patients with poorly controlled diabetes
- •6) Patients with poorly controlled ischemic cardiac disease
- •7) Patients who had prior surgery for prostate (transurethral prostatectomy, radical prostatectomy, orchiectomy, other surgery for BPH and/or hyperthermia)
- •8) Patients who had brachytherapy and/or EBRT
- •9) Patients who are taking steroid drugs (except for ointment)
- •10) Patients who are taking other antiandrogen for BPH
- •11) Patients who had CAB for more than 3 months prior to the registration
- •12) Patients who are judged inappropriate for the clinical trial by doctors
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