Randomised phase 3 trial of enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised, prostate cancer. - ENZARAD Trial

Irish Clinical Oncology Research Group CLG, trading as Cancer Trials Ireland0 sites800 target enrollmentJanuary 20, 2017

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: ocalised prostate cancer at high risk of recurrence
Sponsor: Irish Clinical Oncology Research Group CLG, trading as Cancer Trials Ireland
Enrollment: 800
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

January 20, 2017

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

Irish Clinical Oncology Research Group CLG, trading as Cancer Trials Ireland

•1\.Pathological diagnosis of adenocarcinoma of the prostate, judged to be at high risk for recurrence based on any of the following (in accordance with the ISUP Consensus 2005 (13\) see Appendix 3\):
•?Gleason score 8\-10
•?Gleason score of 4\+3 AND clinical T2b\-4 AND PSA \>20ng/mL OR
•?N1 disease (involvement of lymph nodes at or below the bifurcation of the common iliac arteries) defined radiologically as greater than 10mm on short axis using standard CT or MRI, or biopsy proven
•2\.Age \=18 yrs
•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 \- 2 x ULN, they must have a normal conjugated bilirubin).
•5\.Adequate renal function: calculated creatinine clearance \> 30 ml/min (Cockroft\-Gault)
•6\.ECOG performance status of 0\-1
•7\.Study treatment both planned and able to start within 7 days of randomisation.

•1\.Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
•2\.Involvement of lymph nodes superior to the common iliac bifurcation, and/or outside the pelvis (distant lymph nodes). Lymph node involvement is defined by histopathological confirmation, or by a short axis measurement \>10mm on standard imaging (CT or MRI, but not PET).
•3\.Any contraindication to external beam radiotherapy
•4\.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 grade II or greater, see Appendix 4\), 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.
•5\.Evidence of metastatic disease: minimum imaging required CT / MRI and WBBS. If equivocal bone scan, follow\-up plain films are required to show NO evidence of cancer if not covered by CT/MRI
•6\.PSA \> 100 ng/mL