EUCTR2004-000193-31-GB进行中（未招募）1 期
Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy - STAMPEDE
niversity College London0 个研究点目标入组 12,000 人开始时间: 2020年8月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Participants must fulfil both of the criteria in Section 1 or at least one criterion in Section 2 or at least one criterion in Section 3 of the protocol. Additionally, all patients must fulfil the criteria in Section 4.
- •1. High-Risk Newly-Diagnosed Non-Metastatic Node-Negative Disease
- •At least two of: T category T3/4, PSA =40ng/ml or Gleason sum score 8-10
- •Intention to treat with radical radiotherapy (unless there is a contra-indication; exemption can be sought in advance of consent, after discussion with CTU)
- •2. Newly-Diagnosed Metastatic Or Node-Positive Disease
- •At least one of:
- •Stage T-any N+ M0
- •Stage T-any N-any M+
- •3. Previously Radically Treated, Now Relapsing (Prior Radical Surgery And/or Radiotherapy)
- •At least one of
- •PSA =4ng/ml and rising with doubling time less than 6 months
- •PSA =20ng/ml
- •4. For All Patients
- •I.Histologically confirmed prostate adenocarcinoma
- •II.Intention to treat with long-term androgen deprivation therapy
- •III.Fit for all protocol treatment(1) and follow up, WHO performance status 0-2 (2)
- •IV.Have completed the appropriate investigations prior to randomisation
- •V.Adequate haematological function: neutrophil count =1.5x109/l and platelets =100x109/l
- •VI.Adequate renal function, defined as GFR =30ml/min/1.73m2
- •VII.Written informed consent
- •VIII.Willing and expected to comply with follow up schedule
- •IX.Using effective contraceptive method if applicable
- •(1) Medical contraindications to the trial medications are given in Section 6
- •(2) For WHO performance status definitions see Appendix A
- •Metformin Comparison
- •In addition to the general inclusion and general exclusion criteria the following comparison-specific inclusion criteria must be met to be eligible for randomisation to the metformin comparison:
- •Hb A1c <48mmol/mol (equivalent to <6.5%)
- •Adequate renal function, defined as GFR =45ml/min/1.73m2 (except for Switzerland )
- •No history of lactic acidosis or predisposing conditions
- •No current or previous treatment with metformin
- •No current or previous medication for treatment of diabetes
- •No contraindications to metformin
- •Willingness to join the metabolic sub study
- •*Except Switzerland, please refer to SAKK appendix for local guidance
- •Transdermal Oestradiol Comparison
- •In addition to the general inclusion and exclusion criteria, participants fulfilling all of the following are eligible for the transdermal oestradiol comparison”:
- •=8 weeks of anti-androgen (AR-antagonists) use
- •Maximum of 1 dose of monthly or 4-weekly LHRH agonist/antagonist
- •No prior LHRH agonist injection with a stated duration of effect greater than 1 month
- •=12 weeks since first dose of any hormone therapy
- •Not had a bilateral orchidectomy
- •No use of cyproterone acetate (36) prior to randomisation
- •No known porphyria
- •No known history of deep vein thrombosis or pulmonary embolism confirmed radiologically
- •No known thrombophilic disorder (e.g. Protein C, Protein S, antithrombin deficiency)
- •Not yet started SOC abiraterone, enzalutamide or apalutamide
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4800
- 另有 2 项未显示
排除标准
- •I.Prior systemic therapy for locally advanced or metastatic prostate cancer (except as listed in Section 4.3)
- •II.Prior exposure to hormone therapy for a duration of > 12 months, or prior exposure completing < 12 months before randomisation
- •III.Metastatic brain disease or leptomeningeal disease
- •IV.Abnormal liver functions consisting of any of the following:
- •Serum bilirubin =1.5 x ULN (except for participants with Gilbert’s disease, for whom the upper limit of serum bilirubin is 51.3µmol/l or 3mg/dl)
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =2.5 x ULN - site must indicate at randomisation whether one or both tests are performed at site. Where both results are available both must confirm eligibility.
- •V.Any other previous or current malignant disease which, in the judgement of the responsible clinician, is likely to interfere with STAMPEDE treatment or assessment
- •VI.Any surgical wound (e.g. TURP) which in the judgement of the responsible clinician may interfere with or be exacerbated by protocol treatment
- •VII.Participants with significant cardiovascular disease, including:
- •Severe/unstable angina
- •Myocardial infarction less than 6 months prior to randomisation
- •Arterial thrombotic events less than 6 months prior to randomisation
- •Clinically significant cardiac failure requiring treatment, defined as New York Heart Association (NYHA) class II or above
- •Cerebrovascular disease (e.g. stroke or transient ischaemic episode) less than 6 months prior to randomisation
- •Any other significant cardiovascular disease that in the investigator's opinion means the participant is unfit for any of the study treatments.
- •(1) Excluding participants receiving docetaxel as part of SOC
- •(2) NYHA classifications can be found in Appendix A
研究者
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