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New drug combo aims to stop prostate cancer from spreading

NCT ID NCT02446444

Disease control Sponsor: University of Sydney Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether adding enzalutamide to standard hormone therapy and radiation can delay cancer spread in 802 men with high-risk localized prostate cancer. Participants receive either enzalutamide or a conventional anti-androgen alongside hormone therapy and radiation. The main goal is to see how long men live without the cancer spreading to other parts of the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
enzalutamide
What this could lead to
If successful, this could offer a more effective way to delay cancer spread in men with high-risk localized prostate cancer.
What could go wrong
This is a large phase 3 trial, but results are not yet final. Enzalutamide can cause side effects like fatigue, hot flashes, and high blood pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

802 people

The number who actually took part.

Start date

Mar 2014

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Men with localised prostate cancer at high risk for recurrence deemed suitable for external beam radiation therapy. 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 International Society of Urological Pathology (ISUP) Consensus 2005: 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 2. Age ≥18 years 3. Adequate bone marrow function Haemoglobin (Hb) ≥100g/L and White Cell Count (WCC) ≥ 4.0 x 109/L and platelets ≥100 x 109/L 4. 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). 5. Adequate renal function: calculated creatinine clearance \> 30 ml/min (Cockcroft-Gault) 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 7. Study treatment both planned and able to start within 7 days of randomisation. 8. Willing and able to comply with all study requirements, including treatment, and attending required assessments 9. Has completed the baseline HRQOL questionnaires UNLESS is unable to complete because of literacy or limited vision 10. Signed, written, informed consent 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 * seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma). * loss of consciousness or transient ischemic attack within 12 months of randomization * significant cardiovascular disease within the last 3 months: including myocardial infarction, unstable angina, congestive heart failure (NYHA grade II or greater), ongoing arrhythmias of Grade \> 2 , 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 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 6. PSA \> 100 ng/mL 7. 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). 8. Concurrent illness, including severe infection that might jeopardize 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. 9. 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; 10. Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception. 11. 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. 12. Bilateral orchidectomy or radical prostatectomy 13. Prior brachytherapy or other radiotherapy that would result in an overlap of radiotherapy fields 14. Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases. 15. Major surgery within 21 days prior to randomisation 16. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of enzalutamide, including difficulty swallowing tablets

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma prostate neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostatic neoplasms

Contacts and locations

Locations

  • AZ Groeninge Kortrijk- Campus Kennedylaan

    Kortrijk, 8500, Belgium

  • Addenbrookes Hospital

    Cambridge, United Kingdom

  • Ashford Cancer Centre Research (Adelaide Cancer Centre)

    Kurralta Park, South Australia, 5037, Australia

  • Auckland City Hospital

    Auckland, 1142, New Zealand

  • Austin Health

    Heidelberg, Victoria, 3084, Australia

  • Beacon Private Hospital

    Dublin, Dublin 18, Ireland

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Blacktown Hospital

    Blacktown, New South Wales, 2148, Australia

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298, Australia

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560, Australia

  • Charring Cross Hospital: Imperial College Healthcare NHS Trust

    London, W6 8RF, United Kingdom

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Christchurch Hospital

    Christchurch, 4170, New Zealand

  • Cork University Hospital

    Cork, Co Cork, Ireland

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Eastern Health (Box Hill Hospital)

    Box Hill, Victoria, 3128, Australia

  • Epworth HealthCare - Richmond

    Richmond, Victoria, 3121, Australia

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6149, Australia

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042, Australia

  • Galway University Hospital

    Galway, Co Galway, Ireland

  • Genesis Cancer Care Newcastle

    Gateshead, New South Wales, 2290, Australia

  • Genesis Cancer Care Queensland - Tugun and Southport

    Tugun, Queensland, 4224, Australia

  • Genesis Cancer Care Queensland - Wesley and Chermside

    Auchenflower, Queensland, 4066, Australia

  • Genesis Care - Epping (formerly EROC)

    Epping, Victoria, 3076, Australia

  • Genesis Care - Frankston (formerly FROC)

    Frankston, Victoria, 3199, Australia

  • Genesis Care - Ringwood (formerly RROC)

    Ringwood East, Victoria, 3135, Australia

  • Genesis Care - Western (formerly WROC)

    Footscray, Victoria, 3011, Australia

  • Gosford Hospital

    Gosford, New South Wales, 2250, Australia

  • Guys and St Thomas Hospital

    London, SE1 9RT, United Kingdom

  • Hospital Donostia

    Donostia / San Sebastian, Gipuzkoa, 20014, Spain

  • Hospital Universitario de Salamanca

    Salamanca, 37007, Spain

  • ICON - Gold Coast (formerly ROC Gold Coast)

    Southport, Queensland, 4215, Australia

  • ICON - Toowoomba (formerly ROC Toowoomba)

    Toowoomba, Queensland, 4350, Australia

  • Institut Catala d'Oncologia - ICO Badalona - Hospital Germans Trias i Pujol (Institut Catala D'Oncologia)

    Badalona, Barcelona, 08916, Spain

  • Kent and Canterbury Hospital

    Canterbury, Kent, CT1 3NG, United Kingdom

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Mater Misericordiae University Hospital

    Dublin, Dublin 7, Dublin 7, Ireland

  • Mater Private Hospital

    Dublin, Dublin 7, Ireland

  • Nambour General Hospital

    Nambour, Queensland, 4560, Australia

  • Nottingham City Hospital- City Campus

    Nottingham, NG5 1PB, United Kingdom

  • Orange Health Service

    Orange, New South Wales, 2800, Australia

  • Palmerston North Hospital

    Palmerston North, 4442, New Zealand

  • Peter MacCallum Cancer Centre

    Bendigo, Victoria, 3550, Australia

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3002, Australia

  • Peter MacCallum Cancer Centre (Moorabbin Campus)

    Bentleigh East, Victoria, 3165, Australia

  • Prince of Wales Hospital

    Randwick, New South Wales, 2131, Australia

  • Princess Alexandra Hospital Brisbane

    Woolloongabba, Queensland, 4102, Australia

  • Radiation Oncology Services Mater Centre

    South Brisbane, Queensland, 4101, Australia

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Brisbane & Womens Hospital

    Herston, Queensland, 4006, Australia

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000, Australia

  • Royal Marsden Hospital

    Chelsea, London, SW3 6JJ, United Kingdom

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065, Australia

  • Royal United Hospital Bath

    Bath, BA1 3NG, United Kingdom

  • Salzburger Landeskliniken - Universitätsklinikum Salzburg

    Salzburg, 5020, Austria

  • St George Hospital

    Kogarah, New South Wales, 2217, Australia

  • St Luke's Hospital

    Dublin, Dublin 6, Ireland

  • St Vincent's Hospital

    Sydney, New South Wales, 2010, Australia

  • Sunshine Hospital

    St Albans, Victoria, 3021, Australia

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076, Australia

  • Tamworth Rural Referral Hospital

    Tamworth, New South Wales, 2340, Australia

  • The Institute Of Oncology

    Ljubljana, 1000, Slovenia

  • Townsville Hospital

    Douglas, Queensland, 4814, Australia

  • University Hospital Southhampton

    Southampton, Hampshire, SO16 6YD, United Kingdom

  • University of London Hospital

    London, NW1 2BU, United Kingdom

  • Velindre Hospital

    Whitchurch, Cardiff, CF14 2TL, United Kingdom

  • Western General Hospital

    Edinburgh, Scotland, EH4 2XU, United Kingdom

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Wollongong Hospital

    Wollongong, New South Wales, 2500, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.