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

Phase 1

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

• Registration Number: EUCTR2009-014491-21-GB
• Lead Sponsor: Cambridge University Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-23
• Study Completion: 2013-06-06
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

•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)
•Nx/M0
•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

Exclusion Criteria

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To pilot and test the feasibility of chemotherapy with docetaxel followed by radical prostatectomy for high risk prostate cancer incorporating laboratory and imaging measurements of therapeutic effectiveness, and so investigate whether these measures may be used to define who may benefit from this management strategy. ;<br> Secondary Objective: To establish the basis for a prospective trial of neo-adjuvant docetaxel prior to radical prostatectomy in high risk prostate cancer.<br><br> To compare the value of functional MRI (Dynamic contrast-enhanced MRI [DCE-MRI], diffusion weighed imaging (DWI) or magnetic resonance spectroscopy [MRS]) in detecting prostate cancer tumour volume, activity and any related changes in response to neoadjuvant chemotherapy.<br> ;Primary end point(s): Evidence of a biological and/or pathological and/or imaging change induced by docetaxel therapy on the in vivo prostate tumours prior to surgery.