ISRCTN78176828已完成未知
Radiotherapy with scanning beam protons for locally advanced prostate cancer or localised prostate cancer with risk factors: a phase II non-randomised prospective study
niversity Hospital Essen (Universitatsklinikum Essen) (Germany)0 个研究点目标入组 240 人开始时间: 2009年10月8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
- 240
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
- 性别
- Male
入选标准
- •1. Histologically confirmed prostate cancer with one of the following combinations:
- •1.1. T3-T4 or Gleason greater than or equal to 8 or prostate specific antigen (PSA) greater than 20 and less than 50 ng/ml
- •1.2. T1c-T2a and Gleason 7 and PSA greater than 10 and less than or equal to 20 ng/ml
- •1.3. T2b-T2c and Gleason 7 or PSA greater than 10 and less than or equal to 20 ng/ml
- •2. Performance status World Health Organization (WHO) less than or equal to 2
- •3. No evidence of distant metastases. Minimum work-up: a negative bone scan and an actual PSA-value within 2 months prior to registration are required.
- •4. Negative regional lymph nodes as established by staging lymphadenectomy. For patients denying staging lymphadenectomy, an actual computed tomography (CT) or magnetic resonance imaging (MRI) scan has to be negative for lymph node metastases.
- •5. Men of child-producing potential must be willing to consent to use effective contraception
- •6. Aged greater than or equal to 18 years
- •7. Patients must give study specific informed consent
排除标准
- •1. PSA greater than or equal to 50 ng/ml
- •2. Evidence of distant metastases
- •3. Pathological proven positive lymph nodes or regional lymph nodes greater than 1.0 cm in the smallest diameter on imaging studies
- •4. Prior radical prostatectomy or cryosurgery for prostate cancer
- •5. History of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
- •6. Prior pelvic radiotherapy or brachytherapy
- •7. Prior systemic chemotherapy for the study cancer
- •8. Current or continuing anti-coagulation with Coumadin or equivalent
- •9. Transurethral resection of the prostate or urethrotomia less than 6 months before radiotherapy
- •10. Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any cancer
- •11. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
- •12. Severe, active co-morbidity, defined as follows:
- •12.1. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •12.2. Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
- •12.3. Hip implants
- •12.4. Major medical or psychiatric condition which in the investigators opinion will prevent completion of the treatment and interfere with follow-up
- •12.5. Pre-existing of those gastrointestinal (GI) or genitourinary (GU) symptoms of Grade greater than 1 on the Common Toxicity Criteria (CTC) late effect scale, that are considered for the primary end point
研究者
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