Enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised, prostate cancer.

For men with localised prostate cancer at high risk for recurrence, deemed suitable for external beam radiation therapy.

This study compares hormone treatments used prior to radiotherapy for locally advanced prostate cancers. Patients are randomised to receive standard hormone therapy or a combination that includes Enzalutamide.

This is an international, multicentre trial and is currently recruiting patients through Genesis Cancer Care on the Gold Coast.

Inclusion Criteria:

  • Pathological diagnosis of adenocarcinoma of the prostate, judged to be at high risk for recurrence based on any of the following (ISUP Consensus 2005):
    • Gleason score 8-10
    • Gleason score of 4+3 AND clinical T stage of ≥ T2b AND PSA ≥ 10ng/mL
    • Gleason score 4+3 AND any clinical T stage AND PSA > 20ng/mL
  • Adequate bone marrow, liver, renal and gonadal function as defined by biochemical parameters
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Exclusion Criteria:

  • Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
  • Pelvic lymph nodes greater than 1.5 cm in the short axis on imaging, or evidence of lymph node involvement on histology
  • Any contraindication to external beam radiotherapy
  • History of
    • seizure or any condition that may predispose to seizure
    • loss of consciousness or transient ischemic attack within the last 12 months
    • significant cardiovascular disease within the last 3 months: including myocardial infarction, unstable angina, congestive heart failure, ongoing arrhythmias of Grade > 2 , DVT or PE. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
  • Evidence of metastatic disease
  • PSA > 100 ng/mL
  • History of another malignancy within the last 5 years except for non-melanomatous carcinoma of the skin; or, adequately treated, non-muscle- invasive urothelial carcinoma of the bladder
  • Concurrent illness, including severe infection that might jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
  • Human Immunodeficiency Virus (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.
  • 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:
    • 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
  • History of bilateral hip replacements
  • Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of enzalutamide, including difficulty swallowing tablets

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.

If you are interested, your urologist will be happy to discuss things further and facilitate a referral to the appropriate investigators.