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

Cancer Trials Ireland8 sites in 3 countries79 target enrollmentSeptember 24, 2024

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Cancer Trials Ireland
Enrollment: 79
Locations: 8
Primary Endpoint: Metastasis-free survival (metastasis or death from any cause, MFS)
Status: Active, not recruiting
Last Updated: last year

To determine effects on Metastasis-free survival (metastasis or death from any cause, MFS)

Registry

euclinicaltrials.eu

Start Date

September 24, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

Responsible Party

Principal Investigator

Head of Clinical Operations

Scientific

Cancer Trials Ireland

•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 (16) see Appendix 3): Gleason score 8-10 OR 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.
•Signed, written, informed consent
•Age ≥ 18 yrs
•Adequate bone marrow function: Hb ≥100g/L and WCC ≥ 4.0 x 109/L and platelets ≥100 x 109/L
•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).
•Adequate renal function: calculated creatinine clearance > 30 mL/min (Cockroft-Gault)
•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
•Has completed the baseline HRQL questionnaires UNLESS is unable to complete because of literacy or limited vision

•Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
•Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception.
•Use of hormonal therapy or androgen deprivation therapy, including enzalutamide, except in the following setting: a. Use of LHRHA (with or without anti-androgens) for less than 30 days prior to randomisation in the trial.
•Bilateral orchidectomy or radical prostatectomy
•Prior brachytherapy or other radiotherapy that would result in an overlap of radiotherapy fields
•Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases.
•Major surgery within 21 days prior to randomisation
•Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of enzalutamide, including difficulty swallowing tablets
•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

Metastasis-free survival (metastasis or death from any cause, MFS)

Overall survival (death from any cause, OS)
Prostate cancer specific survival (death from prostate cancer)
PSA progression-free survival (Phoenix criteria, or death from any cause, PSA-PFS)
Clinical progression-free survival (imaging, symptoms, signs, initiation of other anti-cancer treatment, or death from any cause, clinical-PFS)
Time to subsequent hormonal therapy (restarting ADT)
Time to castration-resistant disease (PCWG2 criteria)
Safety (adverse events - CTCAE v4.03)
Health related quality of life (EORTC QLQC-30 & PR-25, EQ-5D-5L)
Health outcomes relative to costs (incremental cost effectiveness ration)