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New drug combo aims to stop High-Risk prostate cancer from spreading

NCT ID NCT04136353

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding darolutamide to standard hormone therapy and radiation can delay cancer spread in men with very high-risk localized prostate cancer. About 1,100 men are participating in this phase 3 trial. The goal is to see if the combination helps keep the cancer from returning or spreading.

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

1,100 people

The number who actually took part.

Started

Mar 2020

Expected to finish

Jul 2028

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.

Inclusion Criteria: 1. Men aged 18 years and older, with pathological diagnosis of adenocarcinoma of the prostate 2. EITHER planned for primary RT and judged to be at very high risk for recurrence based on any of the following: * Grade Group 5, OR * Grade Group 4 AND one or more of the following: clinical T2b-4 OR MRI with seminal vesicle invasion OR extracapsular extension OR PSA\* \> 20ng/mL, OR * Pelvic nodal involvement (involvement of lymph nodes (LNs) at or below the bifurcation of the aorta into the common iliac arteries) defined radiologically as greater than 10mm on short axis using standard CT or MRI, or pathologically confirmed (PSMA PET alone is not considered enough if ≤ 10mm) OR Post-radical prostatectomy ≤ 365 days prior to randomisation and planned for RT with PSA\* ≥ 0.1 ng/mL that has risen or remained stable (within ≤ 0.05 ng/mL) since a previous level at least 1 week earlier, judged to be at very high risk for recurrence based on any of the following: * Grade Group 5, OR * Grade Group 4 AND pT3a or higher, OR * Pelvic nodal involvement (involvement of LNs at or below the bifurcation of the aorta into the common iliac arteries) defined radiologically as greater than 10mm on short axis using standard CT or MRI, or pathologically confirmed (PSMA PET alone is not considered enough if ≤ 10mm) \* This PSA level must be measured within 60 days prior to randomisation. However, if a participant has already commenced endocrine therapy (ET) for prostate cancer, this PSA level must be measured within 180 days prior to commencing ET. 3. Adequate bone marrow function: Haemoglobin ≥ 100g/L, white cell count (WCC) ≥ 4.0x109/L, absolute neutrophil count (ANC) ≥ 1.5x109/L and platelets \> 100 x 109/L 4. Adequate liver function: alanine aminotransferase (ALT) \< 2 x upper limit of normal (ULN) and total bilirubin \< 1.5 x ULN, (or if total 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 (Cockroft-Gault) 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1 7. Study treatment both planned and able to start within 7 days after randomisation 8. Willing to complete health-related quality of life (HRQL) questionnaires UNLESS is unable to complete because of literacy or limited vision 9. Willing and able to comply with all study requirements, including standard of care treatment such as EBRT, timing and/or nature of required assessments 10. Signed, written informed consent Exclusion Criteria: 11. Prostate cancer with predominant non-adenocarcinoma features (sarcomatoid or spindle cell or neuroendocrine small cell or squamous cell components or other non-adenocarcinoma) 12. Involvement of LNs by conventional CT imaging superior to the common iliac artery bifurcation, and/or outside the pelvis (distant LNs). LN involvement is defined by histopathological confirmation, or by a short axis measurement \> 10mm on standard imaging (CT or MRI, but not PET). 13. Evidence of metastatic disease. Minimum imaging requirements to exclude metastatic disease are diagnostic quality imaging of both the pelvis and the abdomen (CT or MRI), chest (CXR or CT), and a whole body radioisotope bone scan (WBBS). * If endocrine therapy (ET) had not started, imaging must be within 60 days prior to randomisation. * If ET has been started, imaging must have been performed no more than 60 days prior to starting ET and no more than 30 days after starting ET and prior to randomisation. 14. PSA \> 100 ng/mL at any time 15. Any prior use of new generation potent AR inhibition (abiraterone, enzalutamide, apalutamide, darolutamide or similar agents). 16. Prior endocrine therapy for prostate cancer except for the following which are allowed: * (i) LHRHA and/or (ii) a first-generation nonsteroidal antiandrogen (NSAA) are allowed if commenced no more than 90 days before randomisation. If an NSAA has been used, it must be stopped before starting study treatment with darolutamide/placebo; and * Prior use of 5-alpha reductase inhibitor is allowed and if used it must be stopped before starting study treatment with darolutamide/placebo 17. Bilateral orchidectomy 18. Prior pelvic brachytherapy or other radiotherapy that would result in an overlap of radiotherapy fields that would preclude the required RT 19. History of * Loss of consciousness or transient ischemic attack or stroke within 6 months prior to randomisation, or * Significant cardiovascular disease within 6 months prior to randomisation: including myocardial infarction, unstable angina, congestive heart failure (NYHA grade II or greater), ongoing arrhythmias of Grade \> 2 (CTCAE v5.0), thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism), coronary artery bypass graft. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed. 20. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of darolutamide, including difficulty swallowing tablets 21. History of another malignancy within 5 years prior to randomisation except for those malignancies treated with curative intent with a predicted risk of relapse of less than 10% including but not limited to non-melanoma carcinoma of the skin; or adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (i.e. Tis, Ta and low grade T1 tumours). All such cases with a history of malignancy within the last 5 years are to be discussed with study team before randomisation. Melanoma in-situ and other adequately treated in-situ neoplasms are not considered malignancies for the purposes of eligibility assessment. 22. Concurrent illness, including severe infection that might jeopardise the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety (HIV infection is not an exclusion criterion if it is controlled with anti-retroviral drugs that are unaffected by concomitant darolutamide) 23. 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 24. Patients who are sexually active with women of child-bearing potential and not willing/able to use medically acceptable and highly effective forms of contraception during study treatment and for at least 4 weeks after completion of study treatment. Contraception must include: * Condom use (also required if sexual partner is pregnant), and * Additional birth control with low failure rate (less than 1% per year) when used consistently and correctly. E.g. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, true sexual abstinence. True sexual abstinence will only be an acceptable form of contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to study treatment, and withdrawal are not acceptable methods of contraception. 25. Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases 26. Major surgery within 21 days prior to randomisation 27. Patients with history of hypersensitivity to the study treatment

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

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

Prostate cancer

Contacts and locations

Locations

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN, United Kingdom

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1, Canada

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037, Australia

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • BC Cancer Agency (BCCA) Fraser Valley

    Surrey, British Columbia, V3V 1Z2, Canada

  • Beacon Private Hospital Dublin

    Dublin, D18 AK68, Ireland

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • Belfast City Hospital

    Belfast, BT9 7AB, United Kingdom

  • Bon Secours Hospital Cork in association with UPMC Hillman Centre

    Cork, T23, Ireland

  • Border Medical Oncology Research Unit

    Albury, New South Wales, 2640, Australia

  • Box Hill Hospital

    Box Hill, Victoria, 3128, Australia

  • Calvary Mater Newcastle

    Newcastle, New South Wales, 2298, Australia

  • Campbelltown hospital

    Sydney, New South Wales, 2560, Australia

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Centre Hospitalier Regional de Trois-Rivieres

    Québec, G8Z 3R9, Canada

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, Canada

  • Centre Integre de Sante et de Services Sociaux de la Monteregie Centre

    Greenfield Park, Quebec, J4V 2H1, Canada

  • Chris O'Brien Lifehouse

    Sydney, New South Wales, 2050, Australia

  • Christchurch Hospital

    Christchurch, 8011, New Zealand

  • Cork University Hospital

    Cork, T12 EC8P, Ireland

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dana Farber Cancer Institute - Milford

    Milford, Massachusetts, 01757, United States

  • Dana Farber Cancer Institute - St. Elizabeth's

    Brighton, Massachusetts, 02135, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dayton Physicians Network

    Kettering, Ohio, 45409, United States

  • Dr. H. Bliss Murphy Cancer Centre, St. John's

    St. John's, Newfoundland and Labrador, A1B 3V6, Canada

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6143, Australia

  • Galway University Hospital

    Galway, H91 YR71, Ireland

  • GenesisCare Cabrini (Gandel Wing), Cabrini Hospital Malvern

    Malvern, Victoria, 3144, Australia

  • GenesisCare Newcastle

    Newcastle, New South Wales, 2290, Australia

  • Gosford Hospital

    Gosford, New South Wales, 2250, Australia

  • Guy's and St Thomas Hospital

    London, SE1 9RT, United Kingdom

  • Hôtel-Dieu de Québec

    Québec, Quebec, G1R 2J6, Canada

  • Icon Cancer Centre

    Southport, Queensland, 4215, Australia

  • Icon Cancer Centre Hobart

    Hobart, Tasmania, 7000, Australia

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG, United Kingdom

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7, Canada

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805, United States

  • Latrobe Regional Hospital

    Traralgon, Victoria, Australia

  • Liverpool Hospital

    Sydney, New South Wales, 2170, Australia

  • Mater Misericordiae University Hospital

    Dublin, D07 A8NN, Ireland

  • Mater Private Dublin

    Dublin, D07 WKW8, Ireland

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • New Jersey Urology Saddle Brook

    Clifton, New Jersey, 07013, United States

  • New Jersey Urology Voorhees

    Voorhees Township, New Jersey, 08043, United States

  • New Mexico Oncology and Hematology Specialists

    Albuquerque, New Mexico, 87109, United States

  • New York University Langone Long Island

    Mineola, New York, 11501, United States

  • New York University Langone Medical Center

    New York, New York, 10016, United States

  • Northern Cancer Institute

    Sydney, New South Wales, 2065, Australia

  • Nottingham University Hospitals NHS Trust - Nottingham City Hospital

    Nottingham, NG5 1PB, United Kingdom

  • Odette Cancer Centre - Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5, Canada

  • Ottawa Hospital Research Institute

    Toronto, Ontario, K1H 8L6, Canada

  • Palmerston North Hospital

    Palmerston North, 4442, New Zealand

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Peter MacCallum Cancer Centre (Moorabbin Campus)

    Bentleigh East, Victoria, 3165, Australia

  • Peter MacCallum Cancer Centre - Bendigo Campus

    Bendigo, Victoria, 3550, Australia

  • Prince of Wales Hospital

    Sydney, New South Wales, 2031, Australia

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Queen Elizabeth II Health Sciences Centre

    London, Ontario, B3H 1V7, Canada

  • ROPART

    Brisbane, Queensland, 4101, Australia

  • Regional Health Authority B, Zone 2 Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2, Canada

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029, Australia

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000, Australia

  • Royal Marsden Hospital

    London, United Kingdom

  • Royal United Hospital Bath

    Bath, BA1 3NG, United Kingdom

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • Sault Area Hospital - Algoma District Cancer Program

    Sault Ste. Marie, Ontario, P6B 0A8, Canada

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Shoalhaven District Memorial Hospital

    Nowra, New South Wales, 2541, Australia

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6006, Australia

  • St George Hospital

    Sydney, New South Wales, 2217, Australia

  • St Luke's Radiation Oncology Network at St James's Hospital

    Dublin, D08 T6T8, Ireland

  • St Vincent's Public Hospital

    Sydney, New South Wales, 2010, Australia

  • St. Luke's Hospital

    Rathgar, Dublin 6, D06 E1C9, Ireland

  • Sunshine Hospital

    St Albans, Victoria, 3021, Australia

  • Sydney Adventist Hospital

    Sydney, New South Wales, 2076, Australia

  • Tallaght University Hospital

    Dublin, D24 NR0A, Ireland

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • Townsville Hospital

    Townsville, Queensland, 4814, Australia

  • Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

  • Western Manitoba Cancer Centre - Prairie Mountain Health

    Brandon, Manitoba, R7A 2B3, Canada

  • William Harvey Hospital

    Ashford, TN24 0LZ, United Kingdom

  • Wollongong Hospital

    Wollongong, New South Wales, 2500, Australia

  • XCancer Omaha/Urology Cancer Center

    Omaha, Nebraska, 68130, United States

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