Randomised phase 3 trial of enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer: ENZAMET - ENZAMET

Cancer Trials Ireland0 sites1,100 target enrollmentAugust 14, 2014

Overview

No summary available.

Registry

who.int

Start Date

August 14, 2014

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•1\.Male aged 18 or older with metastatic adenocarcinoma of the prostate defined by
•?Documented histopathology or cytopathology of prostate adenocarcinoma from a biopsy of a metastatic site
•?Documented histopathology of prostate adenocarcinoma from a TRUS biopsy, radical prostatectomy, or TURP and metastatic disease consistent with prostate cancer.
•?Metastatic disease typical of prostate cancer (i.e. involving bone or pelvic lymph nodes or para\-aortic lymph nodes) AND a serum concentration of PSA that is rising and \>20ng/mL
•2\.Target or non\-target lesions according to RECIST 1\.1
•3\.Adequate bone marrow function: Hb \=100g/L and WCC \= 4\.0 x 109/L and platelets \=100 x 109/L.
•4\.Adequate liver function: ALT \< 2 x ULN and bilirubin \< 1\.5 x ULN, (or if bilirubin is between 1\.5\-2x ULN, they must have a normal conjugated bilirubin). If liver metastases are present ALT must be \< 5xULN
•5\.Adequate renal function: calculated creatinine clearance \> 30 ml/min (Cockroft\-Gault, See Appendix 7\)
•6\.ECOG performance status of 0\-2\. Patients with performance status 2 are only eligible if the decline in performance status is due to metastatic prostate cancer.
•7\.Study treatment both planned and able to start within 7 days after randomisation.

•1\.Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
•2\.History of
•a.seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma).
•b.loss of consciousness or transient ischemic attack within 12 months of randomization
•c.significant cardiovascular disease within the last 3 months including:
•myocardial infarction, unstable angina, congestive heart failure (NYHA functional capacity class II or greater, Refer to Appendix 6\), ongoing arrhythmias of Grade \>2 \[NCI CTCAE, version 4\.03], thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism). Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
•3\.Life expectancy of less than 12 months.
•4\.History of another malignancy within 5 years prior to randomisation, except for either non\-melanomatous carcinoma of the skin or, adequately treated, non\-muscle\-invasive urothelial carcinoma of the bladder (Tis, Ta and low grade T1 tumours).
•5\.Concurrent illness, including severe infection that might jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
•a.HIV\-infection is not an exclusion criterion if it is controlled with anti\-retroviral drugs that are unaffected by concomitant enzalutamide.