Systemic therapy in advanced or metastatic prostate cancer: evaluation of drug efficacy

niversity College London0 个研究点目标入组 11,992 人开始时间: 2004年8月3日最近更新: 2024年7月8日

适应症

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方
入组人数: 11,992

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

研究设计

研究类型: Interventional

入排标准

性别: Male

入选标准

•Participant inclusion criteria as of 14/11/2018:
•Participants must fulfil all the criteria in one of the following three categories:
•1. HIGH-RISK NEWLY DIAGNOSED NON-METASTATIC NODE-NEGATIVE DISEASE - Both:
•1.1. At least two of: Stage T3/4, PSA = 40 ng/ml or Gleason sum score 8-10
•1.2. Intention to treat with radical radiotherapy (unless there is a contra-indication; exemption can sought in advance of consent, after discussion with MRC CTU)
•2. NEWLY DIAGNOSED METASTATIC OR NODE-POSITIVE DISEASE - At least one of:
•2.1. Stage Tany N+ M0
•2.2. Stage Tany Nany M+
•3. PREVIOUSLY TREATED WITH RADICAL SURGERY AND/OR RADIOTHERAPY, NOW RELAPSING - At least one of:
•3.1. PSA = 4 ng/ml and rising with doubling time less than 6 months
•3.2. PSA = 20 ng/ml
•4. FOR ALL PATIENTS
•4.1. Histologically confirmed prostate adenocarcinoma
•4.2. Intention to treat with long-term androgen deprivation therapy
•4.3. Treating clinician and participant should have decided if additional systemic therapy with docetaxel or abiraterone is to be used as part of the standard-of-care prior to randomisation
•4.4 Fit for all protocol treatment2 and follow-up, WHO performance status 0-23
•4.5 Have completed the appropriate investigations prior to randomisation
•4.6. Adequate haematological function: neutrophil count >1.5x109/l and platelets >100x109/l
•4.7. Estimated creatinine clearance >30ml/min
•4.8. Written informed consent
•4.9. Willing and expected to comply with follow-up schedule
•4.10. Using effective contraceptive method if applicable
•Participant inclusion criteria as of 23/01/2013:
•Patients must fulfil both of the criteria in Section 1 or one criterion in Section 2 or at least one criteria in Section 3. Additionally, all patients must fulfil the criteria in Section 4.
•1. HIGH-RISK NEWLY DIAGNOSED NON-METASTATIC NODE-NEGATIVE DISEASE - Both:
•1.1. At least two of: Stage T3/4, PSA = 40 ng/ml or Gleason sum score 8-10
•1.2. Intention to treat with radical radiotherapy (unless there is a contra-indication; exemption can sought in advance of consent, after discussion with MRC CTU)
•2. NEWLY DIAGNOSED METASTATIC OR NODE-POSITIVE DISEASE - At least one of:
•2.1. Stage Tany N+ M0
•2.2. Stage Tany Nany M+
•3. PREVIOUSLY TREATED WITH RADICAL SURGERY AND/OR RADIOTHERAPY, NOW RELAPSING - At least one of:
•3.1. PSA = 4 ng/ml and rising with doubling time less than 6 months
•3.2. PSA = 20 ng/ml
•4. FOR ALL PATIENTS
•4.1. Histologically confirmed prostate adenocarcinoma
•4.2. Intention to treat with long-term androgen deprivation therapy
•4.3. Fit for all protocol treatment2 and follow-up, WHO performance status 0-23
•4.4 Have completed the appropriate investigations prior to randomisation
•4.5. Adequate haematological function: neutrophil count >1.5x109/l and platelets >100x109/l
•4.6. Estimated creatinine clearance >30ml/min
•4.7. Serum potassium =3.5mmol/L
•4.8. Written informed consent
•4.9. Willing and expected to comply with follow-up schedule
•4.10. Using effective contraceptive method if applicable
•Previous inclusion criteria until 23/01/2013:
•Patients must fulfil one of the inclusion criteria in section one or one of the inclusion criteria in section two. Additionally, all patients must fulfil the inclusion criteria in section three:
•Section one - high risk newly diagnosed patients must fulfil one of the following criteria:
•1. Stage T3/4 N0 M0 histologically confirmed prostate adenocarcino

排除标准

•Participant exclusion criteria as of 14/11/2018:
•1. Prior systemic therapy for locally-advanced or metastatic prostate cancer
•2. Metastatic brain disease or leptomeningeal disease
•3. Abnormal liver functions consisting of any of the following:
•3.1. 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)
•3.2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =2.5 x ULN
•4. Any other previous or current malignant disease which, in the judgement of the responsible clinician, is likely to interfere with STAMPEDE treatment or assessment
•5. Any surgery (e.g. TURP) performed within the past 4 weeks
•6. Participants with significant cardiovascular disease, including:
•6.1. Severe/unstable angina
•6.2. Myocardial infarction less than 6 months prior to randomisation
•6.3. Arterial thrombotic events less than 6 months prior to randomisation
•6.4. Clinically significant cardiac failure requiring treatment, defined as New York Heart Association (NYHA) class II or above1
•6.5. Cerebrovascular disease (e.g. stroke or transient ischaemic episode) less than 6 months prior to randomisation
•6.6. Or any other significant cardiovascular disease that in the investigator's opinion means the participant is unfit for any of the study treatments.
•7. Prior chemotherapy for prostate cancer2
•8. Prior exposure to long-term hormone therapy before randomisation
•9. Prior exposure to systemic treatment for prostate cancer (excluding ADT or participants receiving abiraterone as part of SOC)
•Comparison-Specific Selection Criteria
•In addition to the general inclusion and exclusion criteria, the following comparison-specific eligibility criteria apply.
•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:
•1. Hb A1c <48mmol/mol (equivalent to <6.5%)1
•2. Adequate renal function, defined as GFR =45ml/min/1.73m2 (except for Switzerland 2)
•3. No history of lactic acidosis or predisposing conditions
•4. No current or previous treatment with metformin
•5. No contraindications to metformin
•The method used to determine glomerular filtration rate may vary according to local practice. Equations that either estimate glomerular filtration rate (eGFR) or creatinine clearance (CrCl) may be used and the same threshold value applies. Where possible, HbA1c should be performed prior to commencing SOC docetaxel to reduce the likelihood of corticosteroid-related hyperglycaemia impacting on eligibility. All participants with abnormal baseline HbA1c (i.e. 6.5% or higher) should be informed and referred to their GP for further management.
•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”:
•1. =8 weeks of anti-androgen (AR-antagonists) use
•2. =1 dose of monthly or 4-weekly LHRH agonist/antagonist
•3. No prior LHRH agonist injection with a stated duration of effect greater than 1 month
•4. =12 weeks since first dose of any hormone therapy
•5. Not had a bilateral orchidectomy
•6. No use of cyproterone acetate (77) prior to randomisation
•7. No known porphyria
•8. No known history of deep vein thrombosis or pulmonary embolism confirmed radiologically
•9. No known thrombo

研究者

发起方

niversity College London

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