ISRCTN48709247已完成2 期
A randomised phase II trial of Prostate and pelvIs Versus prOsTate Alone treatment for Locally advanced prostate cancer
Institute of Cancer Research (ICR) (UK)0 个研究点目标入组 110 人开始时间: 2011年2月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
研究概览
简要总结
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26104940 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30528653
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Histologically confirmed, non-metastatic adenocarcinoma of the prostate, previously untreated (other than by neoadjuvant hormonal treatment)
- •2. National Collaborative Cancer Network locally advanced disease (T3b or T4) or estimated risk of pelvic lymph node involvement greater than or equal to 30% and either:
- •2.1. Gleason 9 or 10, or
- •2.2. Gleason 8 and one other high risk feature (T3 disease or prostate specific antigen [PSA] greater than 20), or
- •2.3. Gleason 7 and 2 high risk features (T3 disease and PSA greater than or equal to 30)
- •3. World Health Organization (WHO) performance status 0 or 1
- •4. Normal blood count (Hb greater than 11 g/dl, white blood cell count [WBC] greater than 4000/mm3, platelets greater than 100,00/mm3)
- •5. Hormonal therapy for 6 - 9 months duration prior to proposed radiotherapy treatment and PSA less than 4 ng/ml prior to randomisation
- •6. Testosterone level less than 20 ng/dL (0.7 nmol/L)
- •8. Patients must be prepared to attend follow up. All patients participating in the Patient Reported Outcomes (PRO) Study must have adequate cognitive ability to complete the PRO questionnaires.
- •9. Written informed consent
- •10. Male, aged 18 years or older
排除标准
- •1. Prior pelvic radiotherapy
- •2. Prior major pelvic surgery (e.g. colectomy, colostomy, cystectomy, prostatectomy)
- •3. Radiologically suspicious (short axis diameter greater than or equal to 1.0 cm unless biopsied and negative) or pathologically confirmed lymph node involvement
- •4. Life expectancy less than 5 years
- •5. Castrate resistant prostate cancer (rising PSA after LHRHa and anti-androgen)
- •6. Previous active malignancy within the last 5 years other than basal cell carcinoma
- •7. Co-morbid conditions likely to impact on the decision to treat with radiotherapy (e.g. previous inflammatory bowel disease, previous colo-rectal surgery, significant bladder instability or urinary incontinence)
- •8. Bilateral hip prosthesis or fixation which would interfere with standard radiation beam configuration
研究者
相似试验
已完成
Unknown
Partial prostate Ablation versus Radical prosTatectomyProstate cancerCancerISRCTN99760303niversity of Oxford (UK)80
已完成
2 期
A phase II, double-blind, randomised, controlled, dose ranging study to evaluate the safety, immunogenicity, dose response and schedule response of a meningococcal A conjugate vaccine administered concomitantly with local expanded program on immunisation (EPI) vaccines in healthy infantsBacterial meningitisNervous System DiseasesISRCTN82484612Serum Institute of India Limited1,200
已完成
不适用
Cardioprotection in CABG and AVR patients with RIPCISRCTN33084113Imperial College London (UK)120
已完成
2 期
Study of the effectiveness of the addition of Capecitabine to a standard regimen containing Adriamycin®, Cyclophosphamide and Docetaxel as neoadjuvant treatment in large or locally advanced breast cancersarge or locally advanced breast cancerMalignant neoplasm of breastCancerISRCTN00407556nited Lincolnshire Hospitals NHS Trust (UK)130
已完成
2 期
Clinical trial to evaluate the safety and efficacy of CCX140-B in diabetic nephropathyNutritional, Metabolic, EndocrineDiabetic nephropathyISRCTN77691094ChemoCentryx, Inc. (USA)135