ISRCTN72793878已完成未知
A randomised controlled trial to determine the effect of Decapeptyl® on reduction of prostate volume pre-radiotherapy compared with standard therapy (Zoladex®)
niversity Hospitals Bristol NHS Foundation Trust (UK)0 个研究点目标入组 71 人开始时间: 2011年2月7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
- 71
研究概览
简要总结
2017 quality of life results presented at ASCO in https://ascopubs.org/doi/abs/10.1200/JCO.2017.35.6_suppl.62 (added 21/02/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Patients with histologically proven prostate cancer
- •2. Patients who are eligible for and have chosen radical radiotherapy (external beam or brachytherapy) as their treatment
- •3. The patient has given written (personally signed and dated) informed consent before starting any study-related procedure
- •4. The patient is male and is 18 years of age or older
- •5. The patient is able and willing to comply with the requirements of the protocol
- •6. Eastern Cooperative Oncology Group (ECOG) score 0 - 2
排除标准
- •1. Men with stage T4 prostate cancer
- •2. The patient has any contraindication to treatment with anti-androgens or luteinising hormone-releasing hormone agonist (LHRHa) therapy
- •3. The patient has received treatment with any LHRHa or anti-androgen therapy within 1 year prior to study entry
- •4. The patient has been treated with oestrogens or steroid androgens within the 12 months prior to study entry, or is receiving treatment with oestrogens or non-steroid anti-androgens at the time of study entry
- •5. The patient has any condition rendering him unable to understand the nature, scope and possible consequences of the study
- •6. The patient has received any investigational drug therapy within 30 days prior to study entry, or is scheduled to receive such a drug during the study period
- •7. The patient is either scheduled to receive, receiving or anticipated to require any chemotherapy for prostate cancer or any other cancer during the period of his participation in the study
- •8. ECOG score greater than 2
- •9. Previous transurethral resection of the prostate (TURP)
- •10. Current indwelling urethral catheter (Patients performing intermittent self catheterisation are not excluded)
- •11. Prostate volume greater than 100 cc
- •12. Use of 5-alpha reductase inhibitors (Dutasteride, Finasteride) for less than 6 months
- •13. Patient is taking medication that is prohibited by the study protocol
研究者
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