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Randomised phase 3 trial of enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised, prostate cancer: ENZARAD
EU CTIS ID: 2024-514808-13-00
What this study is testing
To determine effects on Metastasis-free survival (metastasis or death from any cause, MFS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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
- 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.
- 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
- 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 a. HIV-infection is not an exclusion criterion if it is controlled with anti-retroviral drugs that are unaffected by concomitant enzalutamide.
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse;
The study team makes the final eligibility decision.
Where it's taking place
- New Zealand
- United States
- Australia
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Zealand; United States; Australia; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.