Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate
DASL-HiCaP
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
2 other identifiers
interventional
1,100
6 countries
93
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Mar 2020
Typical duration for phase_3 prostate-cancer
93 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2019
CompletedFirst Posted
Study publicly available on registry
October 23, 2019
CompletedStudy Start
First participant enrolled
March 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2028
May 6, 2026
May 1, 2026
7.8 years
October 17, 2019
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Through study completion, an average of 5 years
Secondary Outcomes (8)
Overall survival
Through study completion, an average of 5 years
Prostate cancer-specific survival
Through study completion, an average of 5 years
PSA-progression free survival
Through study completion, an average of 5 years
Time to subsequent hormonal therapy
Through study completion, an average of 5 years
Time to castration-resistance
Through study completion, an average of 5 years
- +3 more secondary outcomes
Study Arms (2)
Darolutamide
EXPERIMENTALDarolutamide 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.
Placebo
PLACEBO 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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:
- 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
- +2 more criteria
You may not qualify if:
- 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
- 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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centercollaborator
- Prostate Cancer Clinical Trials Consortiumcollaborator
- University of Sydneylead
- Australian and New Zealand Urogenital and Prostate Cancer Trials Groupcollaborator
- Bayercollaborator
- Cancer Trials Irelandcollaborator
- Canadian Cancer Trials Groupcollaborator
Study Sites (93)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute - St. Elizabeth's
Brighton, Massachusetts, 02135, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Dana Farber Cancer Institute - Milford
Milford, Massachusetts, 01757, United States
XCancer Omaha/Urology Cancer Center
Omaha, Nebraska, 68130, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
New Jersey Urology Saddle Brook
Clifton, New Jersey, 07013, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, 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
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, 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
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Dayton Physicians Network
Kettering, Ohio, 45409, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Border Medical Oncology Research Unit
Albury, New South Wales, 2640, Australia
Gosford Hospital
Gosford, New South Wales, 2250, Australia
GenesisCare Newcastle
Newcastle, New South Wales, 2290, Australia
Calvary Mater Newcastle
Newcastle, New South Wales, 2298, Australia
Shoalhaven District Memorial Hospital
Nowra, New South Wales, 2541, Australia
St Vincent's Public Hospital
Sydney, New South Wales, 2010, Australia
Prince of Wales Hospital
Sydney, New South Wales, 2031, Australia
Chris O'Brien Lifehouse
Sydney, New South Wales, 2050, Australia
Northern Cancer Institute
Sydney, New South Wales, 2065, Australia
Sydney Adventist Hospital
Sydney, New South Wales, 2076, Australia
Liverpool Hospital
Sydney, New South Wales, 2170, Australia
St George Hospital
Sydney, New South Wales, 2217, Australia
Campbelltown hospital
Sydney, New South Wales, 2560, Australia
Wollongong Hospital
Wollongong, New South Wales, 2500, Australia
ROPART
Brisbane, Queensland, 4101, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Icon Cancer Centre
Southport, Queensland, 4215, Australia
Townsville Hospital
Townsville, Queensland, 4814, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037, Australia
Icon Cancer Centre Hobart
Hobart, Tasmania, 7000, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Peter MacCallum Cancer Centre - Bendigo Campus
Bendigo, Victoria, 3550, Australia
Peter MacCallum Cancer Centre (Moorabbin Campus)
Bentleigh East, Victoria, 3165, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
GenesisCare Cabrini (Gandel Wing), Cabrini Hospital Malvern
Malvern, Victoria, 3144, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Sunshine Hospital
St Albans, Victoria, 3021, Australia
Latrobe Regional Hospital
Traralgon, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6143, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6006, Australia
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
BC Cancer Agency (BCCA) Fraser Valley
Surrey, British Columbia, V3V 1Z2, Canada
Western Manitoba Cancer Centre - Prairie Mountain Health
Brandon, Manitoba, R7A 2B3, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Regional Health Authority B, Zone 2 Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
Dr. H. Bliss Murphy Cancer Centre, St. John's
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
Queen Elizabeth II Health Sciences Centre
London, Ontario, B3H 1V7, Canada
Sault Area Hospital - Algoma District Cancer Program
Sault Ste. Marie, Ontario, P6B 0A8, Canada
Ottawa Hospital Research Institute
Toronto, Ontario, K1H 8L6, Canada
Odette Cancer Centre - Sunnybrook Hospital
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Centre Integre de Sante et de Services Sociaux de la Monteregie Centre
Greenfield Park, Quebec, J4V 2H1, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Hôtel-Dieu de Québec
Québec, Quebec, G1R 2J6, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Centre Hospitalier Regional de Trois-Rivieres
Québec, G8Z 3R9, Canada
St. Luke's Hospital
Rathgar, Dublin 6, D06 E1C9, Ireland
Cork University Hospital
Cork, T12 EC8P, Ireland
Bon Secours Hospital Cork in association with UPMC Hillman Centre
Cork, T23, Ireland
Mater Misericordiae University Hospital
Dublin, D07 A8NN, Ireland
Mater Private Dublin
Dublin, D07 WKW8, Ireland
St Luke's Radiation Oncology Network at St James's Hospital
Dublin, D08 T6T8, Ireland
Beacon Private Hospital Dublin
Dublin, D18 AK68, Ireland
Tallaght University Hospital
Dublin, D24 NR0A, Ireland
Galway University Hospital
Galway, H91 YR71, Ireland
Auckland City Hospital
Auckland, 1023, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
Palmerston North Hospital
Palmerston North, 4442, New Zealand
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN, United Kingdom
William Harvey Hospital
Ashford, TN24 0LZ, United Kingdom
Royal United Hospital Bath
Bath, BA1 3NG, United Kingdom
Belfast City Hospital
Belfast, BT9 7AB, United Kingdom
Kent and Canterbury Hospital
Canterbury, CT1 3NG, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
Guy's and St Thomas Hospital
London, SE1 9RT, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Nottingham University Hospitals NHS Trust - Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Christopher Sweeney
Dana-Farber Cancer Institute and Harvard Medical School
- STUDY CHAIR
Tamim Niazi
Jewish General Hospital and McGill University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2019
First Posted
October 23, 2019
Study Start
March 31, 2020
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
July 31, 2028
Last Updated
May 6, 2026
Record last verified: 2026-05