EUCTR2014-003191-23-IE
Active, not recruiting
Phase 1
Randomised phase 3 trial of enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised, prostate cancer: ENZARAD - ENZARAD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cancer Trials Ireland
- Enrollment
- 800
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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.
Exclusion Criteria
- •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 is a CT and/or MRI of the abdomen and pelvis, and a whole body bone scan (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
Outcomes
Primary Outcomes
Not specified
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