eoadjuvant docetaxel prior to radical prostatectomy for high risk localised prostate cancer. Evaluation of biological and functional imaging surrogates of therapy efficacy. - CANCAP01

Cambridge University Hospitals NHS Trust0 个研究点目标入组 15 人开始时间: 2009年10月23日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•High risk prostate cancer: PSA >20 ng/mL or a Gleason score of 8 to 10 or clinical stage T2c and greater (American Urological Association criteria)
•Eastern Cooperative Oncology Group performance status 0 or 1
•Adequate haematological, renal and hepatic function
•Suitable for and selection of radical prostatectomy as therapy
•Informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Age <18 years old
•Previous local radical intervention for prostate cancer
•Previous hormonal or other systemic therapy for prostate cancer
•Previous non skin malignancy
•Having received investigational drug in another clinical study of anticancer therapy within 4 weeks of starting study treatment
•Contraindication to magnetic resonance imaging (MRI) or prostate needle biopsy
•Exclusion criteria related to docetaxel:
•Inadequate organ and bone marrow function as evidenced by:
•Haemoglobin <10.0g/dL
•Absolute neutrophil count < 1.5 x 10.9/L
•Platelet count <100 x 10.9/L
•AST and /or ALT >1.5 x ULN
•Alkaline phosphatase levels > 2.5 x ULN
•Total bilirubin > 1.0 x ULN
•Contraindications to the use of corticosteroid treatment
•Symptomatic peripheral neuropathy grade >2 (National Cancer Institute Common Terminology Criteria V.3)
•Any medical or psychiatric condition which would influence the ability of patients to provide consent
•Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial
•Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease
•requiring antiretroviral therapy.
•Any of the following within 6 months prior to randomization: myocardial infarction,
•Severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack

发起方

Cambridge University Hospitals NHS Trust