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Prostate CancerPhase 3DASL-HiCaPNCT04136353

Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

A Phase 3 study testing Darolutamide, Luteinizing Hormone-Releasing Hormone Analog and External Beam Radiotherapy in people with Prostate Cancer, run by University of Sydney at 93 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to determine the effectiveness of darolutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at very high risk of recurrence. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Darolutamide, Luteinizing Hormone-Releasing Hormone Analog and External Beam Radiotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,100 participants
Where
93 sitesin 6 countries
Study dates
31 Mar 2020to 31 Jul 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men aged 18 years and older, with pathological diagnosis of adenocarcinoma of the prostate
  • 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:
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  • 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.
  • 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
  • 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)
  • Adequate renal function: calculated creatinine clearance > 30 mL/min (Cockroft-Gault)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
  • Study treatment both planned and able to start within 7 days after randomisation
  • Willing to complete health-related quality of life (HRQL) questionnaires UNLESS is unable to complete because of literacy or limited vision
  • Willing and able to comply with all study requirements, including standard of care treatment such as EBRT, timing and/or nature of required assessments
  • Signed, written informed consent

Who cannot join

  • Prostate cancer with predominant non-adenocarcinoma features (sarcomatoid or spindle cell or neuroendocrine small cell or squamous cell components or other non-adenocarcinoma)
  • 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).
  • 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.
  • PSA > 100 ng/mL at any time
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  • Any prior use of new generation potent AR inhibition (abiraterone, enzalutamide, apalutamide, darolutamide or similar agents).
  • 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
  • Bilateral orchidectomy
  • Prior pelvic brachytherapy or other radiotherapy that would result in an overlap of radiotherapy fields that would preclude the required RT
  • 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.
  • Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of darolutamide, including difficulty swallowing tablets
  • 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.
  • 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)
  • 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 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.
  • 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
  • Patients with history of hypersensitivity to the study treatment

Trial locations and contacts

93 sites in 6 countries.

93 sites in 6 countries

Australia32 sites

  • Border Medical Oncology Research Unit

    Albury, New South Wales, 2640

  • Peter MacCallum Cancer Centre - Bendigo Campus

    Bendigo, Victoria, 3550

  • Peter MacCallum Cancer Centre (Moorabbin Campus)

    Bentleigh East, Victoria, 3165

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • ROPART

    Brisbane, Queensland, 4101

  • Gosford Hospital

    Gosford, New South Wales, 2250

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Icon Cancer Centre Hobart

    Hobart, Tasmania, 7000

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

  • GenesisCare Cabrini (Gandel Wing), Cabrini Hospital Malvern

    Malvern, Victoria, 3144

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6143

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6006

  • GenesisCare Newcastle

    Newcastle, New South Wales, 2290

  • Calvary Mater Newcastle

    Newcastle, New South Wales, 2298

  • Shoalhaven District Memorial Hospital

    Nowra, New South Wales, 2541

  • Icon Cancer Centre

    Southport, Queensland, 4215

  • Sunshine Hospital

    St Albans, Victoria, 3021

  • St Vincent's Public Hospital

    Sydney, New South Wales, 2010

  • Prince of Wales Hospital

    Sydney, New South Wales, 2031

  • Chris O'Brien Lifehouse

    Sydney, New South Wales, 2050

  • Northern Cancer Institute

    Sydney, New South Wales, 2065

  • Sydney Adventist Hospital

    Sydney, New South Wales, 2076

  • Liverpool Hospital

    Sydney, New South Wales, 2170

  • St George Hospital

    Sydney, New South Wales, 2217

  • Campbelltown hospital

    Sydney, New South Wales, 2560

  • Townsville Hospital

    Townsville, Queensland, 4814

  • Latrobe Regional Hospital

    Traralgon, Victoria

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada20 sites

  • Western Manitoba Cancer Centre - Prairie Mountain Health

    Brandon, Manitoba, R7A 2B3

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

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

    Greenfield Park, Quebec, J4V 2H1

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

  • Queen Elizabeth II Health Sciences Centre

    London, Ontario, B3H 1V7

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec

  • Hôtel-Dieu de Québec

    Québec, Quebec, G1R 2J6

  • Centre Hospitalier Regional de Trois-Rivieres

    Québec, G8Z 3R9

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

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

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Sault Area Hospital - Algoma District Cancer Program

    Sault Ste. Marie, Ontario, P6B 0A8

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

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

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

  • BC Cancer Agency (BCCA) Fraser Valley

    Surrey, British Columbia, V3V 1Z2

  • Ottawa Hospital Research Institute

    Toronto, Ontario, K1H 8L6

  • Odette Cancer Centre - Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

United States19 sites

  • New Mexico Oncology and Hematology Specialists

    Albuquerque, New Mexico, 87109

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute - St. Elizabeth's

    Brighton, Massachusetts, 02135

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • New Jersey Urology Saddle Brook

    Clifton, New Jersey, 07013

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Dayton Physicians Network

    Kettering, Ohio, 45409

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Dana Farber Cancer Institute - Milford

    Milford, Massachusetts, 01757

  • New York University Langone Long Island

    Mineola, New York, 11501

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • New York University Langone Medical Center

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • XCancer Omaha/Urology Cancer Center

    Omaha, Nebraska, 68130

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

  • New Jersey Urology Voorhees

    Voorhees Township, New Jersey, 08043

Other trials in United States

United Kingdom10 sites

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

  • William Harvey Hospital

    Ashford, TN24 0LZ

  • Royal United Hospital Bath

    Bath, BA1 3NG

  • Belfast City Hospital

    Belfast, BT9 7AB

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Guy's and St Thomas Hospital

    London, SE1 9RT

  • Royal Marsden Hospital

    London

  • Nottingham University Hospitals NHS Trust - Nottingham City Hospital

    Nottingham, NG5 1PB

Other trials in United Kingdom

Ireland9 sites

  • Cork University Hospital

    Cork, T12 EC8P

  • Bon Secours Hospital Cork in association with UPMC Hillman Centre

    Cork, T23

  • Mater Misericordiae University Hospital

    Dublin, D07 A8NN

  • Mater Private Dublin

    Dublin, D07 WKW8

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

    Dublin, D08 T6T8

  • Beacon Private Hospital Dublin

    Dublin, D18 AK68

  • Tallaght University Hospital

    Dublin, D24 NR0A

  • Galway University Hospital

    Galway, H91 YR71

  • St. Luke's Hospital

    Rathgar, Dublin 6, D06 E1C9

Other trials in Ireland

New Zealand3 sites

  • Auckland City Hospital

    Auckland, 1023

  • Christchurch Hospital

    Christchurch, 8011

  • Palmerston North Hospital

    Palmerston North, 4442

Other trials in New Zealand

About this study

Official title: DASL-HiCaP: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801): A Randomised Phase 3 Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localised Prostate Cancer

The purpose of this study is to determine the effectiveness of darolutamide as part of adjuvant androgen deprivation therapy (ADT) with a luteinising hormone releasing hormone analogue (LHRHA) in men having radiation therapy for localised prostate cancer at very high risk of recurrence.

Read the detailed description

This trial aims to demonstrate that the use of darolutamide (in addition to standard of care) will be more effective than current standard of care in enhancing the ability of prostate or prostate bed radiation and 96 weeks of androgen suppression in decreasing the number of patients who develop metastases and subsequently die of prostate cancer. Darolutamide is a novel antagonist of the AR with favourable tolerability due to negligible penetration of the blood-brain barrier. Emergence of metastatic disease is the lethal event after local therapy, either with prostatectomy or definitive radiation. Augmenting adjuvant systemic therapy (either ADT or ADT plus docetaxel) with darolutamide has the potential to eradicate micrometastatic disease after either type of local therapy and decrease the death rate from prostate cancer.

This pragmatic design incorporates current standard of care for all patients and the option for docetaxel to be added to ADT. As such, the data will be applicable for all patients with very high risk prostate cancer treated with local therapy and will be the first study incorporating docetaxel use as one of the standard of care options. Even if docetaxel is definitively proven to improve MFS and OS in the adjuvant setting, not all patients will be fit for docetaxel. This will be the first trial that has the potential to build upon current and future advances that may emerge and be the most effective strategy to decrease death rate from prostate cancer in the near term if it further augments docetaxel efficacy in chemo-fit patients.

Conditions
Prostate Cancer
Being tested
Darolutamide, Placebo oral tablet, Luteinizing Hormone-Releasing Hormone Analog, External Beam Radiotherapy
Keywords
clinically localised prostate cancer, very high risk, darolutamide
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DarolutamideDrug

    2 x 300mg oral tablets twice daily for 96 weeks

  • Placebo oral tabletDrug

    2 oral tablets twice daily for 96 weeks

  • Luteinizing Hormone-Releasing Hormone AnalogDrug

    All participants are to receive standard background therapy with an LHRHA, as per standard of care. The choice of LHRHA is at the discretion of the treating clinician.

  • External Beam RadiotherapyRadiation

    All participants are to receive standard background therapy with curative-intent RT to the prostate or prostate bed as well as the pelvic lymph nodes using EBRT.

Study groups in NCT04136353
Study groupRoleWhat they receive
DarolutamideExperimentalDarolutamide 600mg (2 x 300mg tablets) twice daily by mouth for 96 weeks, adherence monitored by participant report. All participants are treated with an LHRHA for 96 weeks from randomisation and external beam radiation therapy started within 8-24 weeks after randomisation.
Receives: Drug: Darolutamide; Drug: Luteinizing Hormone-Releasing Hormone Analog; Radiation: External Beam Radiotherapy
PlaceboPlacebo comparatorPlacebo (2 tablets) twice daily by mouth for 96 weeks, adherence monitored by participant report. All participants are treated with an LHRHA for 96 weeks from randomisation and external beam radiation therapy started within 8-24 weeks after randomisation.
Receives: Drug: Placebo oral tablet; Drug: Luteinizing Hormone-Releasing Hormone Analog; Radiation: External Beam Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metastasis-free survival

    Evidence of metastases includes findings on WBBS or CT or MRI (as reported by the site investigator) that are either characteristic of metastatic prostate cancer, and/or confirmed by other test results e.g. cytology or histopathology.

    Measured: Through study completion, an average of 5 years

Secondary outcomes (8)

  1. Overall survival

    Overall survival is defined as the interval from the date of randomisation to date of death from any cause, or the date of last known follow-up alive.

    Measured: Through study completion, an average of 5 years

  2. Prostate cancer-specific survival

    Prostate cancer-specific survival is defined as the interval from the date of randomisation to the date of last known follow-up alive, or the date of death from prostate cancer. Deaths from other causes will be summarised.

    Measured: Through study completion, an average of 5 years

  3. PSA-progression free survival

    For participants who receive definitive radiotherapy (i.e. without radical prostatectomy), PSA progression is defined by the Phoenix criteria (requires confirmation by a repeat PSA performed at least 3 weeks later). For participants who have undergone a radical prostatectomy, an increase in PSA of >0.2 ng/mL above the nadir would be considered PSA progression (requires confirmation by a repeat PSA performed at least 3 weeks later).

    Measured: Through study completion, an average of 5 years

  4. Time to subsequent hormonal therapy

    Time to subsequent hormone therapy is the interval from randomisation to the first date that endocrine therapy is recommenced or changed for the treatment of recurrent (or progressive) prostate cancer.

    Measured: Through study completion, an average of 5 years

  5. Time to castration-resistance

    Defined according to the PCWG3 criteria. If a participant has radiographic progression without serological progression, this will also be deemed castration resistant prostate cancer

    Measured: Through study completion, an average of 5 years

  6. Frequency and severity of adverse events (CTCAE v5.0, RTOG/EORTC acute/late radiation morbidity criteria)

    Safety reporting will describe the frequency and severity of AEs. The CTCAE v5.0 will be used to classify and grade the intensity of AEs occurring until 30 days after the last dose of study treatment. The RTOG/EORTC Scoring Criteria will be used to assess morbidities related to radiation therapy (RT) until 6 years after randomisation. Acute AEs are those occurring within 90 days after starting RT, and will be classified and graded according to the RTOG/EORTC Acute Radiation Morbidity Scoring Criteria. Late AEs are those occurring more than 90 days after starting RT, and will be classified and rated according to the RTOG/EORTC Late Radiation Morbidity Scoring Schema.

    Measured: Approximately 12-weekly for 2 years from randomisation until 30 days after the last dose of study treatment.

  7. Health-related quality of life

    EORTC Core Quality of Life Questionnaire (QLQC-30). Importance of quality of life issues are assessed using a four-point scale (1 = not at all, 4 = very much)

    EORTC Quality of Life Questionnaire for Prostate Cancer (PR-25). Importance of quality of life issues are assessed using a four-point scale (1 = not at all, 4 = very much)

    Euroqol 5 item preference-based measure of health (EQ-5D-5L), comprising 5 questions with a score from 1 to 5 each and a visual analogue scale from 0 to 100.

    Measured: Through study completion, an average of 5 years

  8. Fear of cancer recurrence

    Using the Fear of Cancer Recurrence Inventory (FCRI), a 42-item questionnaire with scores of 0 (never/not at all) - 4 (all the time/a great deal) for each.

    Measured: Through study completion, an average of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2019
  2. Study start31 Mar 2020
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04136353
Sponsor's protocol ID
ANZUP1801
Other IDs
U1111-1239-0771
Acronym
DASL-HiCaP
Status last verified
May 2026
First submitted
17 Oct 2019
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Darolutamide, Luteinizing Hormone-Releasing Hormone Analog and External Beam Radiotherapy in people with Prostate Cancer, run by University of Sydney at 93 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in Australia, Canada, United States, United Kingdom, Ireland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Metastasis-free survival (time frame: Through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04136353.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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