Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Loc… (NCT02446444) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer
United States, Australia802 participantsStarted 2014-03
Plain-language summary
The purpose of this study is to determine the effectiveness of enzalutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinizing hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at high risk of recurrence.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. 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 International Society of Urological Pathology (ISUP) Consensus 2005:
✓. Age ≥18 years
✓. Adequate bone marrow function Haemoglobin (Hb) ≥100g/L and White Cell Count (WCC) ≥ 4.0 x 109/L and platelets ≥100 x 109/L
✓. Adequate liver function: Alanine transaminase (ALT) \< 2 x ULN and bilirubin \< 1.5 x Upper Limit of Normal (ULN), (or if bilirubin is between 1.5 - 2 x ULN, they must have a normal conjugated bilirubin).
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
✓. Study treatment both planned and able to start within 7 days of randomisation.
✓. Willing and able to comply with all study requirements, including treatment, and attending required assessments
Exclusion criteria
✕. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
✕. 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).
. Any contraindication to external beam radiotherapy
✕. History of
✕. Evidence of metastatic disease: minimum imaging required Computed tomography scan (CT) / Magnetic Resonance Imaging (MRI) of the abdomen and pelvis, and 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
✕. PSA \> 100 ng/mL
✕. History of another malignancy within 5 years prior to randomisation except for non-melanomatous carcinoma of the skin; or, adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (i.e. Tis, Ta and low grade T1 tumours).
✕. Concurrent illness, including severe infection that might jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety